Breast Cancer
Conditions
Keywords
Asian, Premenopausal, Women, Oophorectomy
Brief summary
This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.
Interventions
DRUGTamoxifen
20 mg po daily x 5 years
PROCEDURESurgery: 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)
Sponsors
International Breast Cancer Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Open for accrual in Asia only * Female age 18-50, * premenopausal with regular cycles (\>25-35 in length) * fine-needle aspiration diagnosis * Stage II-IIIA hormone receptor positive invasive breast cancer * No prior radiation or chemotherapy * Must be surgical candidate for bilateral oophorectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | two- to three-year accrual and initial two or more years of follow-up period | 5-year disease-free survival |
Countries
Morocco, Philippines, Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 244 |
| 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) | 255 |
| 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) | 230 |
| Total | 729 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible post enrollment | 6 | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | C- Immediate Surgery - Nonrandomized | A - Scheduled Surgery | Total | B - Immediate Surgery |
|---|---|---|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 4.4 | 42.2 years STANDARD_DEVIATION 4.5 | 42.2 years STANDARD_DEVIATION 4.5 | 42.3 years STANDARD_DEVIATION 4.7 |
| Estrogen receptor status Negative | 13 participants | 16 participants | 48 participants | 19 participants |
| Estrogen receptor status Positive | 217 participants | 226 participants | 678 participants | 235 participants |
| HER2/Neu status Negative | 153 participants | 146 participants | 459 participants | 160 participants |
| HER2/Neu status Positive | 32 participants | 41 participants | 118 participants | 45 participants |
| Number of positive axillary nodes 1-3 | 56 participants | 60 participants | 189 participants | 73 participants |
| Number of positive axillary nodes 4+ | 68 participants | 81 participants | 219 participants | 70 participants |
| Number of positive axillary nodes None | 103 participants | 96 participants | 310 participants | 111 participants |
| Pathologic tumor size | 4.1 cm STANDARD_DEVIATION 2.3 | 4.5 cm STANDARD_DEVIATION 2.8 | 4.5 cm STANDARD_DEVIATION 2.8 | 4.7 cm STANDARD_DEVIATION 3.2 |
| Progesterone level on day of surgery (ng/ml) <2 | 74 participants | 75 participants | 307 participants | 158 participants |
| Progesterone level on day of surgery (ng/ml) 2-4.99 | 24 participants | 27 participants | 73 participants | 22 participants |
| Progesterone level on day of surgery (ng/ml) 5+ | 117 participants | 118 participants | 292 participants | 57 participants |
| Progesterone receptor status Negative | 11 participants | 25 participants | 56 participants | 20 participants |
| Progesterone receptor status Positive | 219 participants | 218 participants | 671 participants | 234 participants |
| Sex: Female, Male Female | 230 Participants | 244 Participants | 729 Participants | 255 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 244 | 0 / 255 | 0 / 230 |
| serious Total, serious adverse events | 0 / 244 | 5 / 255 | 1 / 230 |
Outcome results
Primary
Disease-free Survival
5-year disease-free survival
Time frame: two- to three-year accrual and initial two or more years of follow-up period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A - Scheduled Surgery | Disease-free Survival | 64 percentage of participants |
| B - Immediate Surgery | Disease-free Survival | 71 percentage of participants |
| C- Immediate Surgery - Nonrandomized | Disease-free Survival | 70 percentage of participants |