Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Southwest Oncology Group
Collaborators:
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
International Breast Cancer Study Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00068601
First received: September 10, 2003
Last updated: February 19, 2012
Last verified: June 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer Infertility Menopausal Symptoms |
Drug: cyclophosphamide Drug: goserelin acetate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Rate of premature ovarian failure at 2 years [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rate of ovarian dysfunction at 1 and 2 years [ Designated as safety issue: No ]
- Ovarian reserve at 1 and 2 years [ Designated as safety issue: No ]
| Estimated Enrollment: | 416 |
| Study Start Date: | October 2003 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: cyclophosphamide
Part of planned chemotherapy regimen
Drug: goserelin acetate
Given subcutaneously
|
|
Active Comparator: Arm II
Patients receive cyclophosphamide-containing chemotherapy alone.
|
Drug: cyclophosphamide
Part of planned chemotherapy regimen
|
Detailed Description:
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 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.
PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068601
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Hide Study LocationsLocations
| Australia, New South Wales | |
| Mater Hospital - North Sydney | |
| North Sydney, New South Wales, Australia, 2060 | |
| Royal North Shore Hospital | |
| St. Leonards, New South Wales, Australia, 2065 | |
| Newcastle Mater Misericordiae Hospital | |
| Waratah, New South Wales, Australia, 2298 | |
| Australia, South Australia | |
| Royal Adelaide Hospital Cancer Centre | |
| Adelaide, South Australia, Australia, 5000 | |
| Flinders Medical Centre | |
| Bedford Park, South Australia, Australia, 5042 | |
| Australia, Tasmania | |
| Royal Hobart Hospital | |
| Hobart, Tasmania, Australia, 7000 | |
| Australia, Victoria | |
| Ballarat Oncology and Haematology Services | |
| Ballarat, Victoria, Australia, 3350 | |
| Box Hill Hospital | |
| Box Hill, Victoria, Australia, 3128 | |
| Monash Medical Center - Clayton Campus | |
| Clayton, Victoria, Australia, 3168 | |
| Peter MacCallum Cancer Centre | |
| East Melbourne, Victoria, Australia, 3002 | |
| Maroondah Hospital | |
| East Ringwood, Victoria, Australia, 3135 | |
| St. Vincent's Hospital - Melbourne | |
| Fitzroy, Victoria, Australia, 3065 | |
| Royal Melbourne Hospital | |
| Parkville, Victoria, Australia, 3050 | |
| Australia, Western Australia | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia, 6000 | |
| Belgium | |
| Centre Hospitalier Hutois | |
| Huy, Belgium, 4500 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Centre Hospitalier Regional de la Citadelle | |
| Liege, Belgium, 4000 | |
| CHU Liege - Domaine Universitaire du Sart Tilman | |
| Liege, Belgium, B-4000 | |
| AZ Damiaan | |
| Oostende, Belgium, 8400 | |
| Centre Hospitalier Peltzer-La Tourelle | |
| Verviers, Belgium, B-4800 | |
| Hungary | |
| National Institute of Oncology | |
| Budapest, Hungary, 1122 | |
| Italy | |
| Ospedali Riuniti di Bergamo | |
| Bergamo, Italy, 24100 | |
| Ospedale degli Infermi - ASL 12 | |
| Biella, Italy, 13900 | |
| Ospedale Civile Ramazzini | |
| Carpi, Italy, 41012 | |
| Ospedale Alessandro Manzoni | |
| Lecco, Italy, 23900 | |
| European Institute of Oncology | |
| Milano, Italy, 20141 | |
| New Zealand | |
| Auckland City Hospital | |
| Auckland, New Zealand, 1 | |
| Switzerland | |
| Oncology Institute of Southern Switzerland | |
| Bellinzona, Switzerland, CH-6500 | |
| Inselspital Bern | |
| Bern, Switzerland, CH-3010 | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, 1011 | |
| Oncology Institute of Southern Switzerland - Locarno | |
| Locarno, Switzerland, CH-6601 | |
| Oncology Institute of Southern Switzerland - Lugano | |
| Lugano, Switzerland, CH-6900 | |
| Oncology Institute of Southern Switzerland - Mendrisio | |
| Mendrisio, Switzerland, CH-6850 | |
| Regionalspital | |
| Thun, Switzerland, 3600 | |
Sponsors and Collaborators
Southwest Oncology Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
International Breast Cancer Study Group
Investigators
| Investigator: | Halle C.F. Moore, MD | The Cleveland Clinic |
| Investigator: | Kathy S. Albain, MD | Loyola University |
| Investigator: | Silvana Martino, DO | John Wayne Cancer Institute at Saint John's Health Center |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Laurence H. Baker, University of Michigan Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00068601 History of Changes |
| Obsolete Identifiers: | NCT00696267 |
| Other Study ID Numbers: | CDR0000327758, SWOG-S0230, CALGB-40401, ECOG-S0230, IBCSG-34-05, EUDRACT-2006-002600-33, EU-20632 |
| Study First Received: | September 10, 2003 |
| Last Updated: | February 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Infertility Menopause, Premature Primary Ovarian Insufficiency Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Genital Diseases, Male Genital Diseases, Female Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |
Cyclophosphamide Goserelin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 19, 2013