Trial Outcomes & Findings for Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer (NCT NCT00201851)
NCT ID: NCT00201851
Last Updated: 2015-04-29
Results Overview
5-year disease-free survival
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
740 participants
Primary outcome timeframe
two- to three-year accrual and initial two or more years of follow-up period
Results posted on
2015-04-29
Participant Flow
Participant milestones
| Measure |
A - Scheduled Surgery
Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
B - Immediate Surgery
Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
C- Immediate Surgery - Nonrandomized
Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
|---|---|---|---|
|
Overall Study
STARTED
|
252
|
257
|
231
|
|
Overall Study
COMPLETED
|
244
|
255
|
230
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
1
|
Reasons for withdrawal
| Measure |
A - Scheduled Surgery
Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
B - Immediate Surgery
Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
C- Immediate Surgery - Nonrandomized
Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
|
Overall Study
Ineligible post enrollment
|
6
|
1
|
1
|
Baseline Characteristics
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
A - Scheduled Surgery
n=244 Participants
Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
B - Immediate Surgery
n=255 Participants
Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
C- Immediate Surgery - Nonrandomized
n=230 Participants
Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
Total
n=729 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 4.5 • n=93 Participants
|
42.3 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
42.1 years
STANDARD_DEVIATION 4.4 • n=27 Participants
|
42.2 years
STANDARD_DEVIATION 4.5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
244 Participants
n=93 Participants
|
255 Participants
n=4 Participants
|
230 Participants
n=27 Participants
|
729 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Estrogen receptor status
Positive
|
226 participants
n=93 Participants
|
235 participants
n=4 Participants
|
217 participants
n=27 Participants
|
678 participants
n=483 Participants
|
|
Estrogen receptor status
Negative
|
16 participants
n=93 Participants
|
19 participants
n=4 Participants
|
13 participants
n=27 Participants
|
48 participants
n=483 Participants
|
|
Progesterone receptor status
Positive
|
218 participants
n=93 Participants
|
234 participants
n=4 Participants
|
219 participants
n=27 Participants
|
671 participants
n=483 Participants
|
|
Progesterone receptor status
Negative
|
25 participants
n=93 Participants
|
20 participants
n=4 Participants
|
11 participants
n=27 Participants
|
56 participants
n=483 Participants
|
|
HER2/Neu status
Positive
|
41 participants
n=93 Participants
|
45 participants
n=4 Participants
|
32 participants
n=27 Participants
|
118 participants
n=483 Participants
|
|
HER2/Neu status
Negative
|
146 participants
n=93 Participants
|
160 participants
n=4 Participants
|
153 participants
n=27 Participants
|
459 participants
n=483 Participants
|
|
Number of positive axillary nodes
None
|
96 participants
n=93 Participants
|
111 participants
n=4 Participants
|
103 participants
n=27 Participants
|
310 participants
n=483 Participants
|
|
Number of positive axillary nodes
1-3
|
60 participants
n=93 Participants
|
73 participants
n=4 Participants
|
56 participants
n=27 Participants
|
189 participants
n=483 Participants
|
|
Number of positive axillary nodes
4+
|
81 participants
n=93 Participants
|
70 participants
n=4 Participants
|
68 participants
n=27 Participants
|
219 participants
n=483 Participants
|
|
Pathologic tumor size
|
4.5 cm
STANDARD_DEVIATION 2.8 • n=93 Participants
|
4.7 cm
STANDARD_DEVIATION 3.2 • n=4 Participants
|
4.1 cm
STANDARD_DEVIATION 2.3 • n=27 Participants
|
4.5 cm
STANDARD_DEVIATION 2.8 • n=483 Participants
|
|
Progesterone level on day of surgery (ng/ml)
<2
|
75 participants
n=93 Participants
|
158 participants
n=4 Participants
|
74 participants
n=27 Participants
|
307 participants
n=483 Participants
|
|
Progesterone level on day of surgery (ng/ml)
2-4.99
|
27 participants
n=93 Participants
|
22 participants
n=4 Participants
|
24 participants
n=27 Participants
|
73 participants
n=483 Participants
|
|
Progesterone level on day of surgery (ng/ml)
5+
|
118 participants
n=93 Participants
|
57 participants
n=4 Participants
|
117 participants
n=27 Participants
|
292 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: two- to three-year accrual and initial two or more years of follow-up period5-year disease-free survival
Outcome measures
| Measure |
A - Scheduled Surgery
n=244 Participants
Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
B - Immediate Surgery
n=255 Participants
Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
C- Immediate Surgery - Nonrandomized
n=230 Participants
Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
|---|---|---|---|
|
Disease-free Survival
|
64 percentage of participants
|
71 percentage of participants
|
70 percentage of participants
|
Adverse Events
A - Scheduled Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B - Immediate Surgery
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
C- Immediate Surgery - Nonrandomized
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A - Scheduled Surgery
n=244 participants at risk
Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
B - Immediate Surgery
n=255 participants at risk
Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
C- Immediate Surgery - Nonrandomized
n=230 participants at risk
Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
Tamoxifen: 20 mg po daily x 5 years
Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
|
|---|---|---|---|
|
Reproductive system and breast disorders
Pregnancy
|
0.00%
0/244 • Over entire course of study
|
0.39%
1/255 • Over entire course of study
|
0.00%
0/230 • Over entire course of study
|
|
Reproductive system and breast disorders
Endocervical cancer
|
0.00%
0/244 • Over entire course of study
|
0.39%
1/255 • Over entire course of study
|
0.00%
0/230 • Over entire course of study
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/244 • Over entire course of study
|
0.39%
1/255 • Over entire course of study
|
0.43%
1/230 • Over entire course of study
|
|
Respiratory, thoracic and mediastinal disorders
Nosocomial pneumonia
|
0.00%
0/244 • Over entire course of study
|
0.78%
2/255 • Over entire course of study
|
0.00%
0/230 • Over entire course of study
|
Other adverse events
Adverse event data not reported
Additional Information
Richard R. Love
International Breast Cancer Research Foundation
Phone: 608-698-7881
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place