At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed invasive breast cancer, stage I–IIIA, operable disease
- ✓Planning to receive 3–8 months of preoperative or postoperative chemotherapy containing alkylating agents (anthracyclines or non-anthracyclines): either 3-month/4-course anthracycline-based, or 6–8-month/course anthracycline-based, or 6–8-month/course non-anthracycline-based regimen
- ✓Estrogen receptor negative and progesterone receptor negative
- ✓Female, age 18–49, premenopausal
- ✕Pregnant or nursing
- ✕Prior cytotoxic chemotherapy
- ✕Prior malignancy except adequately treated basal cell or squamous cell skin cancer or in situ cancer with ≥5 years disease-free survival after curative-intent treatment
- ✕Concurrent hormonal therapy (other than study drug)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
In Brief
A Phase 3 clinical trial evaluating cyclophosphamide and goserelin acetate for Breast Cancer and 2 related conditions. Completed, enrolled 257 participants across 34 sites in 6 countries.
Detailed Summary
RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer. PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.
Study Details
Timeline
Interventions
Part of planned chemotherapy regimen
Given subcutaneously