Phase 3
Completed N=257
S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
Breast Cancer · Infertility · Menopausal Symptoms
Source: ClinicalTrials.gov NCT00068601 ↗
Enrolled (actual)
257
Serious AEs
0.5%
Results posted
Apr 2017
Primary outcomePrimary: Rate of Premature Ovarian Failure at 2 Years — 15; 5 Participants
◆ Published Evidence
Highly cited
543citations · ~49 / year
Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy.
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.
Linked Publications
-
Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Premature Ovarian Failure at 2 Years |
15; 5 | — |
| SECONDARY Rate of Ovarian Dysfunction at 2 Years |
22; 9 | — |
| SECONDARY Rate of Ovarian Dysfunction at 1 Year |
28; 18 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Stage I-IIIA
- Operable disease
- Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative
- Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:
- 3-month/4-course anthracycline-based regimen
- 6- to 8-month/course anthracycline-based regimen
- 6- to 8-month/course non-anthracycline-based regimen
- Hormone receptor status:
- Estrogen receptor negative
- Progesterone receptor negative
PATIENT CHARACTERISTICS:
Age
- 18 to 49
Sex
- Female
Menopausal status
- Premenopausal
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception
- No other prior malignancy except adequately treated basal cell or squamous cell skin cancer or any in situ cancer from which the patient has been disease-free for at least 5 years after treatment with curative intent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No prior cytotoxic chemotherapy
Endocrine therapy
- No other concurrent hormonal therapy
Radiotherapy
- Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed
Surgery
- See Disease Characteristics
Other
- Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed
Data sourced from ClinicalTrials.gov (NCT00068601) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.