Phase 3
N=249
Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00293540 ↗Enrolled (actual)
249
Serious AEs
0.4%
Results posted
Jun 2016
Primary outcome: Primary: Overall Survival — 2.14; 2.00 years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- oophorectomy (Procedure); Tamoxifen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- International Breast Cancer Research Foundation
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
2.14; 2.00 | — |
Summary
This study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.
Eligibility Criteria
Inclusion Criteria
- Estrogen receptor or progesterone receptor positive breast cancer
- Premenopausal with regular menstrual cycles
Exclusion Criteria
- Current oral contraceptives
Data sourced from ClinicalTrials.gov (NCT00293540). 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.