Trial Outcomes & Findings for S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer (NCT NCT00070564)
NCT ID: NCT00070564
Last Updated: 2025-07-31
Results Overview
Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
3294 participants
Primary outcome timeframe
every 6 months (annually for mammograms) for 5 years
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
Arm I
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
678
|
693
|
697
|
648
|
282
|
296
|
|
Overall Study
COMPLETED
|
478
|
490
|
526
|
481
|
203
|
244
|
|
Overall Study
NOT COMPLETED
|
200
|
203
|
171
|
167
|
79
|
52
|
Reasons for withdrawal
| Measure |
Arm I
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Overall Study
Progression
|
2
|
4
|
7
|
7
|
1
|
0
|
|
Overall Study
Delinquent
|
1
|
4
|
2
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
150
|
142
|
120
|
108
|
63
|
36
|
|
Overall Study
Death
|
4
|
1
|
5
|
3
|
0
|
1
|
|
Overall Study
Other, not protocol specified
|
17
|
15
|
14
|
19
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
26
|
37
|
23
|
30
|
8
|
8
|
|
Overall Study
Not reported
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Only females of the total eligible and analyzable patients were included in menopausal status measurement.
Baseline characteristics by cohort
| Measure |
Arm I
n=664 Participants
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
n=683 Participants
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
n=681 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
n=639 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
n=277 Participants
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
ARM VI
n=294 Participants
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
Total
n=3238 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.5 years
n=664 Participants
|
50.9 years
n=683 Participants
|
51.8 years
n=681 Participants
|
50.7 years
n=639 Participants
|
52.7 years
n=277 Participants
|
53.2 years
n=294 Participants
|
52.7 years
n=3238 Participants
|
|
Sex: Female, Male
Female
|
658 Participants
n=664 Participants
|
679 Participants
n=683 Participants
|
676 Participants
n=681 Participants
|
636 Participants
n=639 Participants
|
275 Participants
n=277 Participants
|
291 Participants
n=294 Participants
|
3215 Participants
n=3238 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=664 Participants
|
4 Participants
n=683 Participants
|
5 Participants
n=681 Participants
|
3 Participants
n=639 Participants
|
2 Participants
n=277 Participants
|
3 Participants
n=294 Participants
|
23 Participants
n=3238 Participants
|
|
Black Race
|
73 Participants
n=664 Participants
|
77 Participants
n=683 Participants
|
74 Participants
n=681 Participants
|
78 Participants
n=639 Participants
|
31 Participants
n=277 Participants
|
44 Participants
n=294 Participants
|
377 Participants
n=3238 Participants
|
|
Menopausal status (females)
Premenopausal
|
326 Participants
n=658 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
325 Participants
n=679 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
308 Participants
n=676 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
299 Participants
n=636 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
124 Participants
n=275 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
123 Participants
n=291 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
1505 Participants
n=3215 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
|
Menopausal status (females)
Postmenopausal
|
332 Participants
n=658 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
354 Participants
n=679 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
368 Participants
n=676 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
337 Participants
n=636 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
148 Participants
n=275 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
166 Participants
n=291 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
1705 Participants
n=3215 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
|
Menopausal status (females)
Unknown
|
0 Participants
n=658 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
0 Participants
n=679 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
0 Participants
n=676 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
0 Participants
n=636 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
3 Participants
n=275 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
2 Participants
n=291 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
5 Participants
n=3215 Participants • Only females of the total eligible and analyzable patients were included in menopausal status measurement.
|
|
Nodal status
Negative
|
161 Participants
n=664 Participants
|
153 Participants
n=683 Participants
|
159 Participants
n=681 Participants
|
146 Participants
n=639 Participants
|
105 Participants
n=277 Participants
|
109 Participants
n=294 Participants
|
833 Participants
n=3238 Participants
|
|
Nodal status
1-3 positive nodes
|
260 Participants
n=664 Participants
|
266 Participants
n=683 Participants
|
276 Participants
n=681 Participants
|
245 Participants
n=639 Participants
|
103 Participants
n=277 Participants
|
98 Participants
n=294 Participants
|
1248 Participants
n=3238 Participants
|
|
Nodal status
>= 4 positive nodes
|
241 Participants
n=664 Participants
|
264 Participants
n=683 Participants
|
243 Participants
n=681 Participants
|
244 Participants
n=639 Participants
|
68 Participants
n=277 Participants
|
87 Participants
n=294 Participants
|
1147 Participants
n=3238 Participants
|
|
Nodal status
unknown
|
2 Participants
n=664 Participants
|
0 Participants
n=683 Participants
|
3 Participants
n=681 Participants
|
4 Participants
n=639 Participants
|
1 Participants
n=277 Participants
|
0 Participants
n=294 Participants
|
10 Participants
n=3238 Participants
|
|
ER/PgR
Negative (both negative)
|
212 Participants
n=664 Participants
|
226 Participants
n=683 Participants
|
232 Participants
n=681 Participants
|
206 Participants
n=639 Participants
|
99 Participants
n=277 Participants
|
108 Participants
n=294 Participants
|
1083 Participants
n=3238 Participants
|
|
ER/PgR
Positive (either or both positive)
|
450 Participants
n=664 Participants
|
456 Participants
n=683 Participants
|
446 Participants
n=681 Participants
|
430 Participants
n=639 Participants
|
178 Participants
n=277 Participants
|
185 Participants
n=294 Participants
|
2145 Participants
n=3238 Participants
|
|
ER/PgR
Unknown
|
2 Participants
n=664 Participants
|
1 Participants
n=683 Participants
|
3 Participants
n=681 Participants
|
3 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
1 Participants
n=294 Participants
|
10 Participants
n=3238 Participants
|
|
HER2
Negative
|
528 Participants
n=664 Participants
|
556 Participants
n=683 Participants
|
554 Participants
n=681 Participants
|
525 Participants
n=639 Participants
|
208 Participants
n=277 Participants
|
235 Participants
n=294 Participants
|
2606 Participants
n=3238 Participants
|
|
HER2
Positive
|
125 Participants
n=664 Participants
|
123 Participants
n=683 Participants
|
118 Participants
n=681 Participants
|
109 Participants
n=639 Participants
|
69 Participants
n=277 Participants
|
57 Participants
n=294 Participants
|
601 Participants
n=3238 Participants
|
|
HER2
Unknown
|
11 Participants
n=664 Participants
|
4 Participants
n=683 Participants
|
9 Participants
n=681 Participants
|
5 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
2 Participants
n=294 Participants
|
31 Participants
n=3238 Participants
|
PRIMARY outcome
Timeframe: every 6 months (annually for mammograms) for 5 yearsPopulation: Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.
Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Outcome measures
| Measure |
Arm I
n=664 Participants
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
n=681 Participants
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
n=681 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
n=638 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
n=277 Participants
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
n=294 Participants
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Disease-free Survival
|
83 percentage of participants
Interval 80.0 to 86.0
|
79 percentage of participants
Interval 76.0 to 82.0
|
81 percentage of participants
Interval 78.0 to 84.0
|
81 percentage of participants
Interval 78.0 to 84.0
|
84 percentage of participants
Interval 79.0 to 88.0
|
85 percentage of participants
Interval 80.0 to 89.0
|
PRIMARY outcome
Timeframe: Every 6 months for 5 yearsPopulation: Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.
Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Outcome measures
| Measure |
Arm I
n=664 Participants
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
n=681 Participants
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
n=681 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
n=638 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
n=277 Participants
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
n=294 Participants
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
90 percentage of participants
Interval 87.0 to 92.0
|
87 percentage of participants
Interval 84.0 to 90.0
|
87 percentage of participants
Interval 84.0 to 89.0
|
87 percentage of participants
Interval 84.0 to 90.0
|
90 percentage of participants
Interval 86.0 to 93.0
|
91 percentage of participants
Interval 87.0 to 94.0
|
SECONDARY outcome
Timeframe: Toxicity assessment was evaluated every 4 weeks while on protocol therapy.Population: Limited to patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed.
Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Arm I
n=654 Participants
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
n=663 Participants
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
n=674 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
n=624 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
n=275 Participants
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
n=291 Participants
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fistula, GI - Oral cavity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Pelvis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Rectum
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukocytes (total WBC)
|
128 Participants
|
98 Participants
|
157 Participants
|
128 Participants
|
38 Participants
|
34 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Skin
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
31 Participants
|
29 Participants
|
38 Participants
|
17 Participants
|
8 Participants
|
6 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Watery eye (epiphora, tearing)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Stomach
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
ALT, SGPT (serum glutamic pyruvic transaminase)
|
7 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
AST, SGOT
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acidosis (metabolic or respiratory)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Adult respiratory distress syndrome (ARDS)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Albumin, serum-low (hypoalbuminemia)
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Allergic reaction/hypersensitivity
|
8 Participants
|
12 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
6 Participants
|
5 Participants
|
8 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Apnea
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthritis (non-septic)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ataxia (incoordination)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bilirubin (hyperbilirubinemia)
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bladder spasms
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood/Bone Marrow-Other
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bronchospasm, wheezing
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
CNS cerebrovascular ischemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Calcium, serum-high (hypercalcemia)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Calcium, serum-low (hypocalcemia)
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac General-Other
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac troponin I (cTnI)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac troponin T (cTnT)
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac-ischemia/infarction
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiopulmonary arrest, cause unknown (non-fatal)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cataract
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cholecystitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis, infectious (e.g., Clostridium difficile)
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Conduction abnormality - Asystole
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Confusion
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Constipation
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Constitutional Symptoms-Other
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cough
|
3 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Creatinine
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cystitis
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cytokine release syndrome/acute infusion reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
DIC (disseminated intravascular coagulation)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Death - Multi-organ failure
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Death not associated with CTCAE term - Death NOS
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
8 Participants
|
7 Participants
|
12 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dermatology/Skin-Other
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
27 Participants
|
18 Participants
|
24 Participants
|
23 Participants
|
8 Participants
|
6 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Distention/bloating, abdominal
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness
|
5 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dysphagia (difficulty swallowing)
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea (shortness of breath)
|
21 Participants
|
18 Participants
|
25 Participants
|
16 Participants
|
2 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Edema: head and neck
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Edema: limb
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Encephalopathy
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Endocrine-Other
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Esophagitis
|
5 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Extrapyramidal/involuntary movement/restlessness
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Extremity-upper (function)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Eyelid dysfunction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
FEV(1)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue (asthenia, lethargy, malaise)
|
77 Participants
|
59 Participants
|
87 Participants
|
65 Participants
|
20 Participants
|
14 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
49 Participants
|
9 Participants
|
38 Participants
|
20 Participants
|
16 Participants
|
14 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flu-like syndrome
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fracture
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
GGT (gamma-glutamyl transpeptidase)
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastritis (including bile reflux gastritis)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastrointestinal-Other
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Glucose, serum-high (hyperglycemia)
|
13 Participants
|
17 Participants
|
9 Participants
|
13 Participants
|
6 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Glucose, serum-low (hypoglycemia)
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hair loss/Alopecia (scalp or body)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Heartburn/dyspepsia
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemoglobin
|
87 Participants
|
48 Participants
|
101 Participants
|
47 Participants
|
21 Participants
|
19 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, GI - Lower GI NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, GI - Oral cavity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, GI - Rectum
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, GI - Upper GI NOS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, GU - Urinary NOS
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, GU - Vagina
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage, pulmonary/upper respiratory - Nose
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhage/Bleeding-Other
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhoids
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hot flashes/flushes
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
4 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoxia
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
INR (of prothrombin time)
|
2 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ileus, GI (functional obstruction of bowel)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Bladder
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Colon
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Meninges
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Middle ear
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Paranasal
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - UTI
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf (clin/microbio) w/Gr 3-4 neuts - Wound
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Colon
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Dental
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Esophagus
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Kidney
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
7 Participants
|
5 Participants
|
10 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Meninges
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Muscle
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Neck NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Skin
|
7 Participants
|
6 Participants
|
8 Participants
|
11 Participants
|
4 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
5 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Ungual
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Vagina
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Vulva
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - Wound
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils - perioral
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with normal ANC or Grade 1 or 2 neutroph
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Appendix
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Blood
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Catheter-related
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Foreign body (e.g., g
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Kidney
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Lung (pneumonia)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Skin (cellulitis)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection with unknown ANC - Wound
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infection-Other
|
4 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Injection site reaction/extravasation changes
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Insomnia
|
1 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Intra-operative injury - Peripheral sensory NOS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Intra-operative injury - Spinal cord
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Irregular menses (change from baseline)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Joint-function
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Left ventricular diastolic dysfunction
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Left ventricular systolic dysfunction
|
7 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Liver dysfunction/failure (clinical)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphopenia
|
24 Participants
|
31 Participants
|
26 Participants
|
32 Participants
|
15 Participants
|
18 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Magnesium, serum-low (hypomagnesemia)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Metabolic/Laboratory-Other
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mood alteration - agitation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mood alteration - anxiety
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mood alteration - depression
|
1 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (clinical exam) - Anus
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (clinical exam) - Esophagus
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (clinical exam) - Oral cavity
|
17 Participants
|
56 Participants
|
23 Participants
|
57 Participants
|
4 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (clinical exam) - Pharynx
|
2 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (functional/symp) - Anus
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (functional/symp) - Esophagus
|
2 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (functional/symp) - Oral cav
|
11 Participants
|
38 Participants
|
28 Participants
|
40 Participants
|
1 Participants
|
6 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (functional/symp) - Pharynx
|
4 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (functional/symp) - Rectum
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - Extrem-lower
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - body/general
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Musculoskeletal/Soft Tissue-Other
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myelodysplasia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myocarditis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nail changes
|
4 Participants
|
12 Participants
|
5 Participants
|
9 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nasal cavity/paranasal sinus reactions
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
50 Participants
|
40 Participants
|
53 Participants
|
33 Participants
|
9 Participants
|
9 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neurology-Other
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuropathy: CN V Motor-jaw muscles; Sensory-facial
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuropathy: CN VII Motor-face; Sensory-taste
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuropathy: cranial - CN VIII Hearing and balance
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuropathy: cranial - CN XII Motor-tongue
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuropathy: motor
|
10 Participants
|
13 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuropathy: sensory
|
107 Participants
|
101 Participants
|
76 Participants
|
56 Participants
|
45 Participants
|
25 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophils/granulocytes (ANC/AGC)
|
174 Participants
|
156 Participants
|
218 Participants
|
201 Participants
|
57 Participants
|
65 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Obesity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Obstruction, GI - Small bowel NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Opportunistic inf associated w/gt=Gr 2 lymphopenia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
PTT (Partial thromboplastin time)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Abdomen NOS
|
2 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Anus
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Back
|
0 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Bone
|
10 Participants
|
36 Participants
|
15 Participants
|
9 Participants
|
15 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Breast
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Cardiac/heart
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Chest wall
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Chest/thorax NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Dental/teeth/peridontal
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Esophagus
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Extremity-limb
|
4 Participants
|
9 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Head/headache
|
5 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Joint
|
39 Participants
|
40 Participants
|
21 Participants
|
12 Participants
|
11 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Kidney
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Middle ear
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Muscle
|
42 Participants
|
48 Participants
|
21 Participants
|
11 Participants
|
10 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Neck
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Neuralgia/peripheral nerve
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Pain NOS
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Uterus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain-Other
|
3 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pericardial effusion (non-malignant)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Phosphate, serum-low (hypophosphatemia)
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelets
|
24 Participants
|
21 Participants
|
20 Participants
|
22 Participants
|
6 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pleural effusion (non-malignant)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis/pulmonary infiltrates
|
8 Participants
|
7 Participants
|
11 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Potassium, serum-high (hyperkalemia)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Potassium, serum-low (hypokalemia)
|
18 Participants
|
12 Participants
|
18 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Prolapse of stoma, GI
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Proteinuria
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pruritus/itching
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Psychosis (hallucinations/delusions)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pulmonary/Upper Respiratory-Other
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash/desquamation
|
4 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash: acne/acneiform
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash: hand-foot skin reaction
|
19 Participants
|
95 Participants
|
16 Participants
|
94 Participants
|
3 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Restrictive cardiomyopathy
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Right ventricular dysfunction (cor pulmonale)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rigors/chills
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
SVT and nodal arrhythmia - Atrial fibrillation
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
SVT and nodal arrhythmia - SVT tachycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
SVT and nodal arrhythmia - Sinus tachycardia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Salivary gland changes/saliva
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Secondary Malignancy-poss rel to cancer Tx
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Seizure
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Seroma
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sodium, serum-high (hypernatremia)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sodium, serum-low (hyponatremia)
|
7 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Somnolence/depressed level of consciousness
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sudden death
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope (fainting)
|
5 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syndromes-Other
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Taste alteration (dysgeusia)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombosis/embolism (vascular access-related)
|
9 Participants
|
18 Participants
|
10 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombosis/thrombus/embolism
|
10 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
3 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ulcer, GI - Esophagus
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ulcer, GI - Rectum
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Uric acid, serum-high (hyperuricemia)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urticaria (hives, welts, wheals)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vaginitis (not due to infection)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Valvular heart disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vasovagal episode
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ventricular arrhythmia - PVCs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ventricular arrhythmia - Ventricular tachycardia
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Viral hepatitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vision-blurred vision
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Voice changes/dysarthria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Wound complication, non-infectious
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 yearsPopulation: Patients with HR-positive, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Outcome measures
| Measure |
Arm I
n=375 Participants
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
n=370 Participants
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
n=373 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
n=362 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group
|
82 percentage of participants
Interval 78.0 to 86.0
|
82 percentage of participants
Interval 77.0 to 86.0
|
86 percentage of participants
Interval 82.0 to 89.0
|
85 percentage of participants
Interval 80.0 to 88.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 yearsPopulation: Patients with HR-positive, HER-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Outcome measures
| Measure |
Arm I
n=375 Participants
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
n=370 Participants
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
n=373 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
n=362 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group
|
91 percentage of participants
Interval 87.0 to 93.0
|
92 percentage of participants
Interval 89.0 to 95.0
|
91 percentage of participants
Interval 87.0 to 94.0
|
90 percentage of participants
Interval 86.0 to 93.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 yearsPopulation: Patients with HR-negative, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Outcome measures
| Measure |
Arm I
n=153 Participants
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
n=185 Participants
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
n=180 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
n=162 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group
|
83 percentage of participants
Interval 75.0 to 88.0
|
71 percentage of participants
Interval 63.0 to 77.0
|
72 percentage of participants
Interval 64.0 to 78.0
|
75 percentage of participants
Interval 68.0 to 81.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 yearsPopulation: Patients with HR-negative, HER2-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Outcome measures
| Measure |
Arm I
n=153 Participants
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
n=185 Participants
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
n=180 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
n=162 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group
|
85 percentage of participants
Interval 78.0 to 90.0
|
76 percentage of participants
Interval 69.0 to 82.0
|
78 percentage of participants
Interval 71.0 to 84.0
|
82 percentage of participants
Interval 75.0 to 87.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 yearsPopulation: Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Outcome measures
| Measure |
Arm I
n=125 Participants
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
n=122 Participants
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
n=118 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
n=109 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group
|
85 percentage of participants
Interval 77.0 to 90.0
|
83 percentage of participants
Interval 74.0 to 89.0
|
82 percentage of participants
Interval 74.0 to 88.0
|
80 percentage of participants
Interval 71.0 to 87.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 yearsPopulation: Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.
Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Outcome measures
| Measure |
Arm I
n=125 Participants
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm II
n=122 Participants
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm III
n=118 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm IV
n=109 Participants
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
pegfilgrastim: Given IV
AC regimen: Given IV
cyclophosphamide: Given IV
doxorubicin hydrochloride: Given IV
paclitaxel: Given IV
|
Arm V
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
Arm VI
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.
|
94 percentage of participants
Interval 88.0 to 97.0
|
89 percentage of participants
Interval 81.0 to 94.0
|
89 percentage of participants
Interval 82.0 to 94.0
|
88 percentage of participants
Interval 80.0 to 93.0
|
—
|
—
|
Adverse Events
ARM I
Serious events: 10 serious events
Other events: 381 other events
Deaths: 0 deaths
ARM II
Serious events: 8 serious events
Other events: 412 other events
Deaths: 0 deaths
ARM III
Serious events: 17 serious events
Other events: 389 other events
Deaths: 0 deaths
ARM IV
Serious events: 9 serious events
Other events: 391 other events
Deaths: 0 deaths
ARM V
Serious events: 5 serious events
Other events: 131 other events
Deaths: 0 deaths
ARM VI
Serious events: 8 serious events
Other events: 126 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARM I
n=654 participants at risk
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
ARM II
n=663 participants at risk
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
|
ARM III
n=674 participants at risk
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
ARM IV
n=624 participants at risk
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
|
ARM V
n=275 participants at risk
Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
ARM VI
n=291 participants at risk
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.36%
1/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.69%
2/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Cardiac disorders
Conduction abnormality - Asystole
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.36%
1/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.34%
1/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Cardiac disorders
Ventricular arrhythmia - PVCs
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
General disorders
Constitutional Symptoms-Other
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
General disorders
Death - Multi-organ failure
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.16%
1/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.34%
1/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.32%
2/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.16%
1/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.34%
1/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.34%
1/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.30%
2/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Investigations
AST, SGOT
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Investigations
Cardiac troponin I (cTnI)
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.1%
3/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.34%
1/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy-poss rel to cancer Tx
|
0.31%
2/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.59%
4/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.48%
3/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.36%
1/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.16%
1/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Nervous system disorders
Seizure
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.34%
1/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.34%
1/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome (ARDS)
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.15%
1/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.15%
1/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.30%
2/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.30%
2/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.16%
1/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.00%
0/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
Other adverse events
| Measure |
ARM I
n=654 participants at risk
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
ARM II
n=663 participants at risk
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
|
ARM III
n=674 participants at risk
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
ARM IV
n=624 participants at risk
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
|
ARM V
n=275 participants at risk
Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
|
ARM VI
n=291 participants at risk
(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.5%
49/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.4%
9/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
5.6%
38/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
3.2%
20/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
5.5%
15/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
4.1%
12/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
13.3%
87/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
7.2%
48/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
15.0%
101/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
7.5%
47/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
7.6%
21/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
6.5%
19/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
2.6%
17/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
8.4%
56/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
3.4%
23/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
9.1%
57/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.5%
4/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.0%
3/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
1.7%
11/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
5.7%
38/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
4.2%
28/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
6.4%
40/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.36%
1/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
2.1%
6/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Gastrointestinal disorders
Nausea
|
7.6%
50/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
6.0%
40/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
7.9%
53/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
5.3%
33/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
3.3%
9/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
3.1%
9/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
31/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
4.4%
29/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
5.6%
38/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
2.7%
17/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
2.9%
8/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
2.1%
6/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
11.8%
77/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
8.9%
59/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
12.9%
87/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
10.4%
65/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
7.3%
20/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
4.8%
14/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Investigations
Leukocytes (total WBC)
|
19.6%
128/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
14.8%
98/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
23.3%
157/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
20.5%
128/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
13.8%
38/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
11.7%
34/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Investigations
Lymphopenia
|
3.7%
24/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
4.7%
31/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
3.9%
26/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
5.1%
32/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
5.5%
15/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
6.2%
18/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
26.6%
174/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
23.5%
156/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
32.2%
217/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
32.2%
201/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
19.6%
54/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
22.3%
65/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
1.5%
10/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
5.4%
36/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
2.2%
15/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.4%
9/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
5.5%
15/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
0.34%
1/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
6.0%
39/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
6.0%
40/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
3.1%
21/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.9%
12/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
4.0%
11/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.7%
5/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
6.4%
42/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
7.2%
48/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
3.1%
21/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.8%
11/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
3.6%
10/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.7%
5/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Nervous system disorders
Neuropathy: sensory
|
16.4%
107/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
15.2%
101/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
11.3%
76/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
9.0%
56/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
16.4%
45/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
8.6%
25/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
2.9%
19/654 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
14.3%
95/663 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
2.4%
16/674 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
15.1%
94/624 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.1%
3/275 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
1.4%
4/291 • Toxicity assessment was evaluated every 4 weeks while on protocol therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60