Clinical trial · Interventional
Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]
- 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)
RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer. PURPOSE: This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I, stage II, or stage III breast cancer.
Conditions
Conditions (3)
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 |
| Infertility | — | UNRESOLVED | — |
| Menopausal Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fertility assessment and management | Procedure | — | UNRESOLVED |
| goserelin acetate | Drug | Goserelin | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
Secondary outcomes (6)
- measure
- Incidence of menopausal symptoms
- measure
- Quality of life
- measure
- Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers
- measure
- Hormone levels (including follicle-stimulating hormone, luteinizing hormone, beta-inhibin, and estradiol) as measured after course 3, after course 6 or 8 (depending on chemotherapy regimen), at 9 and 12 months, and then annually for up to 5 years
- measure
- Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer * Stages I-IIIB with node-positive or -negative disease (N0-2) * Operable disease * Must meet 1 of the following criteria: * Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks * Scheduled to receive neoadjuvant chemotherapy * No metastatic breast cancer, including supraclavicular fossa metastases * Hormone receptor status meeting 1 of the following criteria: * Estrogen receptor (ER) and progesterone receptor poor or negative AND not a candidate for adjuvant endocrine therapy * ER positive AND no requirement for ovarian suppression as a necessary part of treatment PATIENT CHARACTERISTICS: * Female * Premenopausal with regular menses in the 12 months preceding surgery * No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Suitable fitness status for chemotherapy * Adequate hepatic, renal, and bone marrow function * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy or endocrine therapy
References
Publications (0)
Data not yet available