S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
NCT ID: NCT00068601
Last Updated: 2019-12-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
257 participants
INTERVENTIONAL
2003-10-31
2016-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard Chemotherapy
Patients receive cyclophosphamide-containing chemotherapy alone.
cyclophosphamide
Part of planned chemotherapy regimen
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.
cyclophosphamide
Part of planned chemotherapy regimen
goserelin acetate
Given subcutaneously
Interventions
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cyclophosphamide
Part of planned chemotherapy regimen
goserelin acetate
Given subcutaneously
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
49 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Cancer and Leukemia Group B
NETWORK
Eastern Cooperative Oncology Group
NETWORK
ETOP IBCSG Partners Foundation
NETWORK
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Halle C Moore, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Kathy S. Albain, MD
Role: STUDY_CHAIR
Loyola University
Silvana Martino, DO
Role: STUDY_CHAIR
Saint John's Cancer Institute
Ann H. Partridge, MD, MPH
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Lori J. Goldstein, MD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Kelly-Anne Phillips
Role: STUDY_CHAIR
Peter MacCallum Cancer Centre, Australia
Locations
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Auckland City Hospital
Auckland, , New Zealand
Oncology Institute of Southern Switzerland
Bellinzona, , Switzerland
Inselspital Bern
Bern, , Switzerland
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
Liège, , Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
Liège, , Belgium
AZ Damiaan
Ostend, , 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
Milan, , Italy
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
Countries
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References
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Moore HC, Unger JM, Phillips KA, Boyle F, Hitre E, Porter D, Francis PA, Goldstein LJ, Gomez HL, Vallejos CS, Partridge AH, Dakhil SR, Garcia AA, Gralow J, Lombard JM, Forbes JF, Martino S, Barlow WE, Fabian CJ, Minasian L, Meyskens FL Jr, Gelber RD, Hortobagyi GN, Albain KS; POEMS/S0230 Investigators. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N Engl J Med. 2015 Mar 5;372(10):923-32. doi: 10.1056/NEJMoa1413204.
Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.
Other Identifiers
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S0230
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB-40401
Identifier Type: OTHER
Identifier Source: secondary_id
IBCSG-34-05
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000327758
Identifier Type: -
Identifier Source: org_study_id
NCT00696267
Identifier Type: -
Identifier Source: nct_alias