Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Supportive care | Closed | 18 to 49 | NCI | SWOG-S0230 CALGB-40401, ECOG-S0230, NCT00068601, IBCSG-34-05, EUDRACT-2006-002600-33, EU-20632 |
Objectives
Primary
- Compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy with vs without goserelin.
Secondary
- Compare the rate of ovarian dysfunction in patients treated with these regimens.
- Compare ovarian reserve in patients treated with these regimens.
- Describe the pregnancy rates in patients treated with these regimens.
Entry 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
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
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
Expected Enrollment
416A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.
Outcomes
Primary Outcome(s)Rate of premature ovarian failure at 2 years
Rate of ovarian dysfunction at 1 and 2 years
Ovarian reserve at 1 and 2 years
Outline
This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3- to 4-month/course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 3- to 4-month/course non-anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive cyclophosphamide-containing chemotherapy alone.
Patients are followed at 1, 2, and 5 years.
Trial Lead Organizations
Southwest Oncology Group
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| Halle Moore, MD, Study coordinator | |
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| Kathy Albain, MD, Study coordinator | |
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| Silvana Martino, DO, Study coordinator | |
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Cancer and Leukemia Group B
| | | |
| Ann Partridge, MD, MPH, Protocol chair | |
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Eastern Cooperative Oncology Group
| | | ||
| Lori Goldstein, MD, Protocol chair | |
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International Breast Cancer Study Group
| | | |
| Kelly-Anne Phillips, Protocol chair | |
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Related Information
PDQ® clinical trial SWOG-S0221
| Registry Information | ||
| ||
| Official Title | Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer | |
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| Trial Start Date | 2003-10-01 | |
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| Trial Completion Date | 2016-01-01 (estimated) | |
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| Registered in ClinicalTrials.gov | NCT00068601 | |
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| Date Submitted to PDQ | 2003-07-28 | |
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| Information Last Verified | 2011-06-02 | |
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| NCI Grant/Contract Number | CA32102 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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