Trial Outcomes & Findings for S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer (NCT NCT00856492)
NCT ID: NCT00856492
Last Updated: 2017-06-27
Results Overview
Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
215 participants
Primary outcome timeframe
pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)
Results posted on
2017-06-27
Participant Flow
Participant milestones
| Measure |
Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G))
Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
|
Arm 2 (Nab-Paclitaxel / AC+PEG-G)
Received nP x 12 without bevacizumab followed by ddAC x 6
|
Arm 3 (AC+PEG-G / Nab-Paclitaxel)
ddAC x 6 followed by nP x 12 without bevacizumab
|
|---|---|---|---|
|
Overall Study
STARTED
|
99
|
63
|
53
|
|
Overall Study
Toxicity Eval
|
96
|
60
|
51
|
|
Overall Study
COMPLETED
|
98
|
62
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G))
Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
|
Arm 2 (Nab-Paclitaxel / AC+PEG-G)
Received nP x 12 without bevacizumab followed by ddAC x 6
|
Arm 3 (AC+PEG-G / Nab-Paclitaxel)
ddAC x 6 followed by nP x 12 without bevacizumab
|
|---|---|---|---|
|
Overall Study
Ineligible or withdrew consent
|
1
|
1
|
2
|
Baseline Characteristics
One subject missing Breast cancer stage information at baseline.
Baseline characteristics by cohort
| Measure |
Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)
n=98 Participants
Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
|
Arm 2 (Nab-Paclitaxel / AC+PEG-G))
n=62 Participants
Received nP x 12 followed by ddAC x 6 without bevacizumab
|
Arm 3 (AC+PEG-G / Nab-Paclitaxel)
n=51 Participants
Received ddAC x 6 first followed by nP x 12, without bevacizumab
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.7 years
n=98 Participants
|
49.7 years
n=62 Participants
|
51.6 years
n=51 Participants
|
51.5 years
n=211 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=98 Participants
|
62 Participants
n=62 Participants
|
51 Participants
n=51 Participants
|
211 Participants
n=211 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=98 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=211 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
70 Participants
n=98 Participants
|
44 Participants
n=62 Participants
|
40 Participants
n=51 Participants
|
154 Participants
n=211 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
20 Participants
n=98 Participants
|
14 Participants
n=62 Participants
|
4 Participants
n=51 Participants
|
38 Participants
n=211 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian/Pacific Islander
|
5 Participants
n=98 Participants
|
1 Participants
n=62 Participants
|
5 Participants
n=51 Participants
|
11 Participants
n=211 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other/unknown
|
3 Participants
n=98 Participants
|
3 Participants
n=62 Participants
|
2 Participants
n=51 Participants
|
8 Participants
n=211 Participants
|
|
Inflammatory Breast Cancer (IBC) or Non-IBC Locally Advanced Breast Cancer (LABC)
IBC
|
10 Participants
n=98 Participants
|
7 Participants
n=62 Participants
|
7 Participants
n=51 Participants
|
24 Participants
n=211 Participants
|
|
Inflammatory Breast Cancer (IBC) or Non-IBC Locally Advanced Breast Cancer (LABC)
Non-IBC LABC
|
88 Participants
n=98 Participants
|
55 Participants
n=62 Participants
|
44 Participants
n=51 Participants
|
187 Participants
n=211 Participants
|
|
Hormone receptor status
Positive: ER+ or PgR+
|
66 Participants
n=98 Participants
|
43 Participants
n=62 Participants
|
35 Participants
n=51 Participants
|
144 Participants
n=211 Participants
|
|
Hormone receptor status
Negative: ER- and PR- (TNBC)
|
32 Participants
n=98 Participants
|
19 Participants
n=62 Participants
|
16 Participants
n=51 Participants
|
67 Participants
n=211 Participants
|
|
Breast cancer stage
IIB
|
35 Participants
n=98 Participants • One subject missing Breast cancer stage information at baseline.
|
30 Participants
n=62 Participants • One subject missing Breast cancer stage information at baseline.
|
22 Participants
n=50 Participants • One subject missing Breast cancer stage information at baseline.
|
87 Participants
n=210 Participants • One subject missing Breast cancer stage information at baseline.
|
|
Breast cancer stage
IIIA
|
32 Participants
n=98 Participants • One subject missing Breast cancer stage information at baseline.
|
16 Participants
n=62 Participants • One subject missing Breast cancer stage information at baseline.
|
14 Participants
n=50 Participants • One subject missing Breast cancer stage information at baseline.
|
62 Participants
n=210 Participants • One subject missing Breast cancer stage information at baseline.
|
|
Breast cancer stage
IIIB
|
29 Participants
n=98 Participants • One subject missing Breast cancer stage information at baseline.
|
12 Participants
n=62 Participants • One subject missing Breast cancer stage information at baseline.
|
12 Participants
n=50 Participants • One subject missing Breast cancer stage information at baseline.
|
53 Participants
n=210 Participants • One subject missing Breast cancer stage information at baseline.
|
|
Breast cancer stage
IIIC
|
2 Participants
n=98 Participants • One subject missing Breast cancer stage information at baseline.
|
4 Participants
n=62 Participants • One subject missing Breast cancer stage information at baseline.
|
2 Participants
n=50 Participants • One subject missing Breast cancer stage information at baseline.
|
8 Participants
n=210 Participants • One subject missing Breast cancer stage information at baseline.
|
PRIMARY outcome
Timeframe: pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)Population: Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab
Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.
Outcome measures
| Measure |
Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))
n=98 Participants
Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
|
Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))
n=113 Participants
Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
|
Arm III (AC+PEG-G - Nab-Paclitaxel)
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
|
|---|---|---|---|
|
Number of Patients With Pathological Complete Response Rate
|
35 Participants
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration.Population: Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab
Time from registration to death due to any cause
Outcome measures
| Measure |
Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))
n=98 Participants
Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
|
Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))
n=113 Participants
Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
|
Arm III (AC+PEG-G - Nab-Paclitaxel)
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
|
|---|---|---|---|
|
Overall Survival
|
14 deaths
|
17 deaths
|
—
|
SECONDARY outcome
Timeframe: Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrencePopulation: Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab
Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause.
Outcome measures
| Measure |
Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))
n=98 Participants
Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
|
Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))
n=113 Participants
Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
|
Arm III (AC+PEG-G - Nab-Paclitaxel)
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
|
|---|---|---|---|
|
Event-free Survival
|
20 participants
|
24 participants
|
—
|
SECONDARY outcome
Timeframe: Up to 28 weeksPopulation: All participants receiving at least some protocol treatment
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))
n=96 Participants
Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
|
Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))
n=60 Participants
Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
|
Arm III (AC+PEG-G - Nab-Paclitaxel)
n=51 Participants
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
|
|---|---|---|---|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Abdominal pain
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Adult respiratory distress syndrome
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Alanine aminotransferase increased
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Anemia
|
13 Participants
|
6 Participants
|
13 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Anorectal infection
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Anxiety
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Blood and lymphatic system disorders - Other
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Bone pain
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
CD4 lymphocytes decreased
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Catheter related infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Chest wall pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Confusion
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Conjunctivitis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Dehydration
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Dental caries
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Depression
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Device related infection
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Diarrhea
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Dysphagia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Dyspnea
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Ear pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Edema limbs
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Ejection fraction decreased
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Enterocolitis
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Enterocolitis infectious
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Erythema multiforme
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Facial nerve disorder
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Facial pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Fatigue
|
7 Participants
|
7 Participants
|
4 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Febrile neutropenia
|
10 Participants
|
5 Participants
|
3 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Gait disturbance
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Gastrointestinal disorders - Other, specify
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Generalized muscle weakness
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Headache
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Heart failure
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Hypercalcemia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Hyperglycemia
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Hypertension
|
8 Participants
|
2 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Hypokalemia
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Hyponatremia
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Hypophosphatemia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Hypotension
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Insomnia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Leukocytosis
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Lung infection
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Lymphocyte count decreased
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Mucositis oral
|
6 Participants
|
2 Participants
|
5 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Myalgia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Nasal congestion
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Nausea
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Neutrophil count decreased
|
36 Participants
|
10 Participants
|
16 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Non-cardiac chest pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Oral pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Otitis externa
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Pain
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Pain in extremity
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Palmar-plantar erythrodysesthesia syndrome
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Periorbital infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Peripheral motor neuropathy
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Peripheral sensory neuropathy
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Platelet count decreased
|
6 Participants
|
3 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Pneumonitis
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Proctitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Proteinuria
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Rash maculo-papular
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Rectal pain
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Renal and urinary disorders - Other, specify
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Respiratory failure
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Sepsis
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Skin and subcutaneous tissue disorders - Other
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Skin infection
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Suicide attempt
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Syncope
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Thromboembolic event
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Tooth infection
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Urinary tract infection
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Vomiting
|
9 Participants
|
3 Participants
|
2 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Vulval infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Weight gain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Weight loss
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
White blood cell decreased
|
15 Participants
|
5 Participants
|
12 Participants
|
Adverse Events
Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))
Serious events: 22 serious events
Other events: 92 other events
Deaths: 0 deaths
Arm II (Nab-Paclitaxel - AC+PEG-G)
Serious events: 3 serious events
Other events: 58 other events
Deaths: 0 deaths
Arm III (AC+PEG-G - Nab-Paclitaxel)
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))
n=96 participants at risk
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
|
Arm II (Nab-Paclitaxel - AC+PEG-G)
n=60 participants at risk
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
|
Arm III (AC+PEG-G - Nab-Paclitaxel)
n=51 participants at risk
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
1/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
4/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Cardiac disorders
Heart failure
|
1.0%
1/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
2/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
General disorders
Death NOS
|
0.00%
0/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
General disorders
Pain
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Infections and infestations
Catheter related infection
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Infections and infestations
Lung infection
|
0.00%
0/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Infections and infestations
Sepsis
|
2.1%
2/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Infections and infestations
Skin infection
|
2.1%
2/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Investigations
Ejection fraction decreased
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Investigations
Investigations-Other
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Investigations
Neutrophil count decreased
|
5.2%
5/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
Investigations
Platelet count decreased
|
1.0%
1/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Investigations
Weight gain
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Investigations
White blood cell decreased
|
4.2%
4/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Nervous system disorders
Headache
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Psychiatric disorders
Confusion
|
2.1%
2/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.0%
1/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
2/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Vascular disorders
Hypertension
|
2.1%
2/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Vascular disorders
Thromboembolic event
|
2.1%
2/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
Other adverse events
| Measure |
Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))
n=96 participants at risk
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
|
Arm II (Nab-Paclitaxel - AC+PEG-G)
n=60 participants at risk
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
|
Arm III (AC+PEG-G - Nab-Paclitaxel)
n=51 participants at risk
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
76.0%
73/96 • Up to 25 weeks
|
71.7%
43/60 • Up to 25 weeks
|
94.1%
48/51 • Up to 25 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.3%
7/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
5.2%
5/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
4/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Eye disorders
Blurred vision
|
6.2%
6/96 • Up to 25 weeks
|
13.3%
8/60 • Up to 25 weeks
|
9.8%
5/51 • Up to 25 weeks
|
|
Eye disorders
Conjunctivitis
|
2.1%
2/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Eye disorders
Dry eye
|
3.1%
3/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Eye disorders
Eye disorders-Other
|
5.2%
5/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
Eye disorders
Watering eyes
|
20.8%
20/96 • Up to 25 weeks
|
11.7%
7/60 • Up to 25 weeks
|
21.6%
11/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
13.5%
13/96 • Up to 25 weeks
|
11.7%
7/60 • Up to 25 weeks
|
15.7%
8/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Anal pain
|
4.2%
4/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Bloating
|
4.2%
4/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Constipation
|
54.2%
52/96 • Up to 25 weeks
|
40.0%
24/60 • Up to 25 weeks
|
51.0%
26/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
47.9%
46/96 • Up to 25 weeks
|
51.7%
31/60 • Up to 25 weeks
|
52.9%
27/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
5.2%
5/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
9.8%
5/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
17.7%
17/96 • Up to 25 weeks
|
11.7%
7/60 • Up to 25 weeks
|
29.4%
15/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
9.4%
9/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
8/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
9.8%
5/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
6.2%
6/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.2%
6/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
43.8%
42/96 • Up to 25 weeks
|
43.3%
26/60 • Up to 25 weeks
|
56.9%
29/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Nausea
|
76.0%
73/96 • Up to 25 weeks
|
81.7%
49/60 • Up to 25 weeks
|
80.4%
41/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Oral pain
|
5.2%
5/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
6.2%
6/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
2.1%
2/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Gastrointestinal disorders
Vomiting
|
36.5%
35/96 • Up to 25 weeks
|
53.3%
32/60 • Up to 25 weeks
|
54.9%
28/51 • Up to 25 weeks
|
|
General disorders
Chills
|
14.6%
14/96 • Up to 25 weeks
|
11.7%
7/60 • Up to 25 weeks
|
15.7%
8/51 • Up to 25 weeks
|
|
General disorders
Edema limbs
|
8.3%
8/96 • Up to 25 weeks
|
20.0%
12/60 • Up to 25 weeks
|
17.6%
9/51 • Up to 25 weeks
|
|
General disorders
Fatigue
|
88.5%
85/96 • Up to 25 weeks
|
83.3%
50/60 • Up to 25 weeks
|
88.2%
45/51 • Up to 25 weeks
|
|
General disorders
Fever
|
12.5%
12/96 • Up to 25 weeks
|
11.7%
7/60 • Up to 25 weeks
|
23.5%
12/51 • Up to 25 weeks
|
|
General disorders
Flu like symptoms
|
4.2%
4/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
General disorders
Non-cardiac chest pain
|
1.0%
1/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
General disorders
Pain
|
35.4%
34/96 • Up to 25 weeks
|
38.3%
23/60 • Up to 25 weeks
|
19.6%
10/51 • Up to 25 weeks
|
|
Infections and infestations
Bronchial infection
|
1.0%
1/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Infections and infestations
Infections and infestations-Other
|
3.1%
3/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Infections and infestations
Lung infection
|
2.1%
2/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Infections and infestations
Nail infection
|
14.6%
14/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
Infections and infestations
Sinusitis
|
6.2%
6/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Infections and infestations
Skin infection
|
10.4%
10/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
13.7%
7/51 • Up to 25 weeks
|
|
Infections and infestations
Tooth infection
|
2.1%
2/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
Infections and infestations
Upper respiratory infection
|
8.3%
8/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
15.7%
8/51 • Up to 25 weeks
|
|
Infections and infestations
Urinary tract infection
|
7.3%
7/96 • Up to 25 weeks
|
10.0%
6/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Investigations
Alanine aminotransferase increased
|
32.3%
31/96 • Up to 25 weeks
|
30.0%
18/60 • Up to 25 weeks
|
31.4%
16/51 • Up to 25 weeks
|
|
Investigations
Alkaline phosphatase increased
|
20.8%
20/96 • Up to 25 weeks
|
13.3%
8/60 • Up to 25 weeks
|
31.4%
16/51 • Up to 25 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
26.0%
25/96 • Up to 25 weeks
|
28.3%
17/60 • Up to 25 weeks
|
37.3%
19/51 • Up to 25 weeks
|
|
Investigations
CD4 lymphocytes decreased
|
1.0%
1/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Investigations
Creatinine increased
|
8.3%
8/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
Investigations
Investigations-Other
|
10.4%
10/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Investigations
Lymphocyte count decreased
|
6.2%
6/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
15.7%
8/51 • Up to 25 weeks
|
|
Investigations
Neutrophil count decreased
|
60.4%
58/96 • Up to 25 weeks
|
40.0%
24/60 • Up to 25 weeks
|
51.0%
26/51 • Up to 25 weeks
|
|
Investigations
Platelet count decreased
|
21.9%
21/96 • Up to 25 weeks
|
18.3%
11/60 • Up to 25 weeks
|
25.5%
13/51 • Up to 25 weeks
|
|
Investigations
Weight loss
|
28.1%
27/96 • Up to 25 weeks
|
10.0%
6/60 • Up to 25 weeks
|
25.5%
13/51 • Up to 25 weeks
|
|
Investigations
White blood cell decreased
|
50.0%
48/96 • Up to 25 weeks
|
36.7%
22/60 • Up to 25 weeks
|
56.9%
29/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
36.5%
35/96 • Up to 25 weeks
|
31.7%
19/60 • Up to 25 weeks
|
39.2%
20/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
8/96 • Up to 25 weeks
|
8.3%
5/60 • Up to 25 weeks
|
13.7%
7/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
32/96 • Up to 25 weeks
|
23.3%
14/60 • Up to 25 weeks
|
37.3%
19/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.7%
17/96 • Up to 25 weeks
|
11.7%
7/60 • Up to 25 weeks
|
21.6%
11/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
21.9%
21/96 • Up to 25 weeks
|
10.0%
6/60 • Up to 25 weeks
|
9.8%
5/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.2%
4/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.9%
22/96 • Up to 25 weeks
|
18.3%
11/60 • Up to 25 weeks
|
37.3%
19/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.3%
7/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.6%
14/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
21.6%
11/51 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
24/96 • Up to 25 weeks
|
20.0%
12/60 • Up to 25 weeks
|
25.5%
13/51 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.6%
14/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
13.7%
7/51 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
8/96 • Up to 25 weeks
|
20.0%
12/60 • Up to 25 weeks
|
25.5%
13/51 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.1%
3/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.2%
5/96 • Up to 25 weeks
|
13.3%
8/60 • Up to 25 weeks
|
11.8%
6/51 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.1%
27/96 • Up to 25 weeks
|
15.0%
9/60 • Up to 25 weeks
|
33.3%
17/51 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
6/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.8%
19/96 • Up to 25 weeks
|
16.7%
10/60 • Up to 25 weeks
|
15.7%
8/51 • Up to 25 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.0%
1/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Nervous system disorders
Dizziness
|
24.0%
23/96 • Up to 25 weeks
|
20.0%
12/60 • Up to 25 weeks
|
31.4%
16/51 • Up to 25 weeks
|
|
Nervous system disorders
Dysgeusia
|
36.5%
35/96 • Up to 25 weeks
|
18.3%
11/60 • Up to 25 weeks
|
17.6%
9/51 • Up to 25 weeks
|
|
Nervous system disorders
Headache
|
46.9%
45/96 • Up to 25 weeks
|
43.3%
26/60 • Up to 25 weeks
|
37.3%
19/51 • Up to 25 weeks
|
|
Nervous system disorders
Memory impairment
|
4.2%
4/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Nervous system disorders
Paresthesia
|
3.1%
3/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.2%
4/96 • Up to 25 weeks
|
8.3%
5/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
71.9%
69/96 • Up to 25 weeks
|
66.7%
40/60 • Up to 25 weeks
|
58.8%
30/51 • Up to 25 weeks
|
|
Psychiatric disorders
Anxiety
|
15.6%
15/96 • Up to 25 weeks
|
16.7%
10/60 • Up to 25 weeks
|
13.7%
7/51 • Up to 25 weeks
|
|
Psychiatric disorders
Depression
|
17.7%
17/96 • Up to 25 weeks
|
15.0%
9/60 • Up to 25 weeks
|
17.6%
9/51 • Up to 25 weeks
|
|
Psychiatric disorders
Insomnia
|
34.4%
33/96 • Up to 25 weeks
|
25.0%
15/60 • Up to 25 weeks
|
19.6%
10/51 • Up to 25 weeks
|
|
Renal and urinary disorders
Proteinuria
|
7.3%
7/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Renal and urinary disorders
Urinary frequency
|
4.2%
4/96 • Up to 25 weeks
|
0.00%
0/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Renal and urinary disorders
Urinary tract pain
|
5.2%
5/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
16.7%
16/96 • Up to 25 weeks
|
16.7%
10/60 • Up to 25 weeks
|
11.8%
6/51 • Up to 25 weeks
|
|
Reproductive system and breast disorders
Irregular menstruation
|
3.1%
3/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
17.7%
17/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
15.7%
8/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
32/96 • Up to 25 weeks
|
23.3%
14/60 • Up to 25 weeks
|
31.4%
16/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
36/96 • Up to 25 weeks
|
31.7%
19/60 • Up to 25 weeks
|
41.2%
21/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
44.8%
43/96 • Up to 25 weeks
|
8.3%
5/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.3%
8/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
0.00%
0/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
16/96 • Up to 25 weeks
|
15.0%
9/60 • Up to 25 weeks
|
11.8%
6/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.2%
6/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.3%
7/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
12.5%
12/96 • Up to 25 weeks
|
8.3%
5/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
16/96 • Up to 25 weeks
|
8.3%
5/60 • Up to 25 weeks
|
9.8%
5/51 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.1%
3/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.3%
56/96 • Up to 25 weeks
|
61.7%
37/60 • Up to 25 weeks
|
58.8%
30/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.4%
10/96 • Up to 25 weeks
|
11.7%
7/60 • Up to 25 weeks
|
19.6%
10/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.2%
4/96 • Up to 25 weeks
|
5.0%
3/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
31.2%
30/96 • Up to 25 weeks
|
25.0%
15/60 • Up to 25 weeks
|
37.3%
19/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
13.5%
13/96 • Up to 25 weeks
|
8.3%
5/60 • Up to 25 weeks
|
15.7%
8/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
13.5%
13/96 • Up to 25 weeks
|
8.3%
5/60 • Up to 25 weeks
|
11.8%
6/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
7.3%
7/96 • Up to 25 weeks
|
3.3%
2/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
5.2%
5/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
11.8%
6/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
16/96 • Up to 25 weeks
|
16.7%
10/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.5%
13/96 • Up to 25 weeks
|
11.7%
7/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
38.5%
37/96 • Up to 25 weeks
|
16.7%
10/60 • Up to 25 weeks
|
19.6%
10/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
12.5%
12/96 • Up to 25 weeks
|
8.3%
5/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
14.6%
14/96 • Up to 25 weeks
|
8.3%
5/60 • Up to 25 weeks
|
5.9%
3/51 • Up to 25 weeks
|
|
Vascular disorders
Flushing
|
5.2%
5/96 • Up to 25 weeks
|
1.7%
1/60 • Up to 25 weeks
|
2.0%
1/51 • Up to 25 weeks
|
|
Vascular disorders
Hot flashes
|
20.8%
20/96 • Up to 25 weeks
|
18.3%
11/60 • Up to 25 weeks
|
25.5%
13/51 • Up to 25 weeks
|
|
Vascular disorders
Hypertension
|
37.5%
36/96 • Up to 25 weeks
|
16.7%
10/60 • Up to 25 weeks
|
9.8%
5/51 • Up to 25 weeks
|
|
Vascular disorders
Hypotension
|
12.5%
12/96 • Up to 25 weeks
|
8.3%
5/60 • Up to 25 weeks
|
7.8%
4/51 • Up to 25 weeks
|
|
Vascular disorders
Thromboembolic event
|
5.2%
5/96 • Up to 25 weeks
|
6.7%
4/60 • Up to 25 weeks
|
3.9%
2/51 • Up to 25 weeks
|
Additional Information
Breast Committee Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60