Clinical trial · Interventional
Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer
Phase III Randomized Study of Luteal Phase vs. Follicular Phase Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor-Positive Breast Cancer
NCT00293540CI-TRIAL-00023262completedPhase 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 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.
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 |
|---|---|---|---|
| oophorectomy | Procedure | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Surgical oophorectomy in history-estimated mid-luteal phase of menstrual cycle plus Tamoxifen
- interventionNames
- Procedure: oophorectomy
- Drug: Tamoxifen
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Surgical oophorectomy in history-estimated mid-follicular phase of menstrual cycle plus Tamoxifen
- interventionNames
- Procedure: oophorectomy
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Estrogen receptor or progesterone receptor positive breast cancer * Premenopausal with regular menstrual cycles Exclusion Criteria: * Current oral contraceptives
References
Publications (1)
- DERIVEDLove RR, Hossain SM, Hussain MM, Mostafa MG, Laudico AV, Siguan SS, Adebamowo C, Sun JZ, Fei F, Shao ZM, Liu Y, Akram Hussain SM, Zhang B, Cheng L, Panigaro S, Walta F, Chuan JH, Mirasol-Lumague MR, Yip CH, Navarro NS Jr, Huang CS, Lu YS, Ferdousy T, Salim R, Akhter C, Nahar S, Uy G, Young GS, Hade EM, Jarjoura D. Luteal versus follicular phase surgical oophorectomy plus tamoxifen in premenopausal women with metastatic hormone receptor-positive breast cancer. Eur J Cancer. 2016 Jun;60:107-16. doi: 10.1016/j.ejca.2016.03.011. Epub 2016 Apr 20. PMID 27107325