Phase 3
Completed N=740
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Source: ClinicalTrials.gov NCT00201851 ↗Enrolled (actual)
740
Serious AEs
0.8%
Results posted
Apr 2015
Primary outcomePrimary: Disease-free Survival — 64; 71; 70 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-free Survival |
64; 71; 70 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00201851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.