S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00068601 |
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Recruitment Status :
Completed
First Posted : September 11, 2003
Results First Posted : April 4, 2017
Last Update Posted : December 30, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Infertility Menopausal Symptoms | Drug: cyclophosphamide Drug: goserelin acetate | Phase 3 |
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.
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 1: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are followed at 1, 2, and 5 years.
- Arm 2: 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.
PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 257 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| 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 |
| Study Start Date : | October 2003 |
| Actual Primary Completion Date : | January 2014 |
| Actual Study Completion Date : | September 2016 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard Chemotherapy
Patients receive cyclophosphamide-containing chemotherapy alone.
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Drug: cyclophosphamide
Part of planned chemotherapy regimen |
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Experimental: Chemotherapy Plus Goserelin
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.
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Drug: cyclophosphamide
Part of planned chemotherapy regimen Drug: goserelin acetate Given subcutaneously |
- Rate of Premature Ovarian Failure at 2 Years [ Time Frame: 2 years ]Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.
- Rate of Ovarian Dysfunction at 2 Years [ Time Frame: 2 years ]Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.
- Rate of Ovarian Dysfunction at 1 Year [ Time Frame: 1 year ]Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.
- Ovarian Reserve at 1 and 2 Years [ Time Frame: 1 and 2 years ]Measurements of ovarian reserve will consist of "Day 2 - 4" levels of FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic, anytime during Month 12/13 and Month 24/25).
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| Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068601
Show 34 study locations
| Principal Investigator: | Halle C Moore, MD | The Cleveland Clinic | |
| Study Chair: | Kathy S. Albain, MD | Loyola University | |
| Study Chair: | Silvana Martino, DO | Saint John's Cancer Institute | |
| Study Chair: | Ann H. Partridge, MD, MPH | Dana-Farber Cancer Institute | |
| Study Chair: | Lori J. Goldstein, MD | Fox Chase Cancer Center | |
| Study Chair: | Kelly-Anne Phillips | Peter MacCallum Cancer Centre, Australia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | SWOG Cancer Research Network |
| ClinicalTrials.gov Identifier: | NCT00068601 |
| Obsolete Identifiers: | NCT00696267 |
| Other Study ID Numbers: |
CDR0000327758 S0230 ( Other Identifier: SWOG ) CALGB-40401 ( Other Identifier: CALGB ) IBCSG-34-05 ( Other Identifier: IBCSG ) U10CA037429 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 11, 2003 Key Record Dates |
| Results First Posted: | April 4, 2017 |
| Last Update Posted: | December 30, 2019 |
| Last Verified: | December 2019 |
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infertility menopausal symptoms stage II breast cancer stage IIIA breast cancer |
stage IA breast cancer stage IB breast cancer estrogen receptor-negative breast cancer progesterone receptor-negative breast cancer |
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Breast Neoplasms Infertility Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Genital Diseases Urogenital Diseases Cyclophosphamide Goserelin |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Hormonal |