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Study 6 of 6485 for search of: | United States, Ohio |
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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B Eastern Cooperative Oncology Group International Breast Cancer Study Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00068601 |
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 |
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Breast Cancer Cancer-Related Problem/Condition |
Drug: cyclophosphamide Drug: goserelin |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Active Control |
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 |
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 |
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Arm I: Experimental
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
Given subcutaneously
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Arm II: Active Comparator
Patients receive cyclophosphamide-containing chemotherapy alone.
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Drug: cyclophosphamide
Part of planned chemotherapy regimen
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3-month/4-course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
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:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
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: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00068601 |
Health Authority: | Unspecified |
sexual dysfunction and infertility menopausal symptoms stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Infertility Skin Diseases Gonadal Disorders Goserelin Breast Neoplasms Endocrine System Diseases Ovarian Failure, Premature |
Ovarian Diseases Cyclophosphamide Genital Diseases, Female Endocrinopathy Breast Diseases Menopause |
Antineoplastic Agents, Hormonal Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |