Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer
| Registry | NCT00201851 |
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| Status | Completed |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 740 (Actual) |
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| Sponsor | International Breast Cancer Research Foundation (Other) |
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| Conditions | Breast Cancer |
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| Interventions | Tamoxifen, Surgery: Oophorectomy (Drug, procedure) |
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| Dates | start 2004-01-01, primary completion 2011-12-01, completion 2013-05-01, first posted 2005-09-20, last updated 2015-04-29 |
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| Locations | 9 sites in Morocco, Philippines, Vietnam |
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Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer All trials of Tamoxifen All trials of Surgery: Oophorectomy
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Immediate surgery | Active comparator | Drug: Tamoxifen; Procedure: Surgery: Oophorectomy | Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen |
| Scheduled surgery | Experimental | Drug: Tamoxifen; Procedure: Surgery: Oophorectomy | Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen |
| Immediate Surgery - nonrandomized | Other | Drug: Tamoxifen; Procedure: Surgery: Oophorectomy | Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization |
- Tamoxifen (Drug), also known as Nolvadex®: 20 mg po daily x 5 years
- Surgery: Oophorectomy (Procedure), also known as ovary removal surgery: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
+Outcome measures
Primary outcomes
- Disease-free Survival [two- to three-year accrual and initial two or more years of follow-up period]: 5-year disease-free survival
+Eligibility
Sex: Female, ages: 18 Years to 50 Years
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
+Posted results
Participant flow
| Milestone | A - Scheduled Surgery | B - Immediate Surgery | C- Immediate Surgery - Nonrandomized |
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| Started | 252 | 257 | 231 |
| Completed | 244 | 255 | 230 |
| Not completed | 8 | 2 | 1 |
Outcome results
- Disease-free Survival (Primary), Number, percentage of participants: A - Scheduled Surgery 64; B - Immediate Surgery 71; C- Immediate Surgery - Nonrandomized 70
Adverse events
Time frame: Over entire course of study
| Arm | Deaths | Serious adverse events | Other adverse events |
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| A - Scheduled Surgery | 0 | 0/244 (0.0%) | 0/244 (0.0%) |
| B - Immediate Surgery | 0 | 5/255 (2.0%) | 0/255 (0.0%) |
| C- Immediate Surgery - Nonrandomized | 0 | 1/230 (0.4%) | 0/230 (0.0%) |
Serious adverse events by term
| Term | Organ system | A - Scheduled Surgery | B - Immediate Surgery | C- Immediate Surgery - Nonrandomized |
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| Pregnancy | Reproductive system and breast disorders | 0/244 | 1/255 | 0/230 |
| Endocervical cancer | Reproductive system and breast disorders | 0/244 | 1/255 | 0/230 |
| Venous thrombosis | Vascular disorders | 0/244 | 1/255 | 1/230 |
| Nosocomial pneumonia | Respiratory, thoracic and mediastinal disorders | 0/244 | 2/255 | 0/230 |
+Locations (9)
| Facility | City | Country | Status |
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| National Institute of Oncology | Rabat | Morocco | |
| Vicente Soto Memorial Medical Center | Cebu | Philippines | |
| East Avenue Medical Center | Manila | Philippines | |
| Philippine General Hospital | Manila | Philippines | |
| Rizal | Manila | Philippines | |
| Santo Toma Hospital | Manila | Philippines | |
| Danang General | Da Nang | Vietnam | |
| Hospital K, National Cancer Institute | Hanoi | Vietnam | |
| Hue Central | Huế | Vietnam | |
+Publications
- Results publication: Hade 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
+Investigators