Spots Global Cancer Trial Database for S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
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Trial Identification
Brief Title: S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
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 ID: NCT00068601
Study Description
Brief 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.
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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Mater Hospital - North Sydney, North Sydney, New South Wales, Australia
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, Australia
Royal Adelaide Hospital Cancer Centre, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Ballarat Oncology and Haematology Services, Ballarat, Victoria, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Monash Medical Center - Clayton Campus, Clayton, Victoria, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
Maroondah Hospital, East Ringwood, Victoria, Australia
St. Vincent's Hospital - Melbourne, Fitzroy, Victoria, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Centre Hospitalier Hutois, Huy, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Centre Hospitalier Regional de la Citadelle, Liege, , Belgium
CHU Liege - Domaine Universitaire du Sart Tilman, Liege, , Belgium
AZ Damiaan, Oostende, , Belgium
Centre Hospitalier Peltzer-La Tourelle, Verviers, , Belgium
National Institute of Oncology, Budapest, , Hungary
Ospedali Riuniti di Bergamo, Bergamo, , Italy
Ospedale degli Infermi - ASL 12, Biella, , Italy
Ospedale Civile Ramazzini, Carpi, , Italy
Ospedale Alessandro Manzoni, Lecco, , Italy
European Institute of Oncology, Milano, , Italy
Auckland City Hospital, Auckland, , New Zealand
Oncology Institute of Southern Switzerland, Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Oncology Institute of Southern Switzerland - Locarno, Locarno, , Switzerland
Oncology Institute of Southern Switzerland - Lugano, Lugano, , Switzerland
Oncology Institute of Southern Switzerland - Mendrisio, Mendrisio, , Switzerland
Regionalspital, Thun, , Switzerland
Contact Details
Name: Halle C Moore, MD
Affiliation: The Cleveland Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Kathy S. Albain, MD
Affiliation: Loyola University
Role: STUDY_CHAIR
Name: Silvana Martino, DO
Affiliation: Saint John's Cancer Institute
Role: STUDY_CHAIR
Name: Ann H. Partridge, MD, MPH
Affiliation: Dana-Farber Cancer Institute
Role: STUDY_CHAIR
Name: Lori J. Goldstein, MD
Affiliation: Fox Chase Cancer Center
Role: STUDY_CHAIR
Name: Kelly-Anne Phillips
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: STUDY_CHAIR
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