Clinical trial · Interventional
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer
NCT00201851CI-TRIAL-00017676completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery: Oophorectomy | Procedure | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Immediate surgery
- description
- Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
- interventionNames
- Drug: Tamoxifen
- Procedure: Surgery: Oophorectomy
- type
- EXPERIMENTAL
- label
- Scheduled surgery
- description
- Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
- interventionNames
- Drug: Tamoxifen
- Procedure: Surgery: Oophorectomy
- type
- OTHER
- label
- Immediate Surgery - nonrandomized
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHade EM, Young GS, Love RR. Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival. Trials. 2019 Aug 23;20(1):527. doi: 10.1186/s13063-019-3632-9. PMID 31443726