Phase 3 N=740 Randomized Treatment

Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00201851 ↗

Enrolled (actual)

740

Serious AEs

0.8%

Results posted

Apr 2015

Primary outcome: Primary: Disease-free Survival — 64; 71; 70 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tamoxifen (Drug); Surgery: Oophorectomy (Procedure)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: International Breast Cancer Research Foundation
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Disease-free Survival	64; 71; 70	—

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.

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

View full record on ClinicalTrials.gov →

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.