S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer

NCT00068601 | Completed Phase 3 Results DMC

• 5 other identifiers: CDR0000327758S0230CALGB-40401IBCSG-34-05U10CA037429
• Study Type: interventional
• Target: 257
• Locations: 6 countries
• Sites: 34

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.

Conditions

Breast Cancer; Infertility; Menopausal Symptoms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of Premature Ovarian Failure at 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.

  2 years

Secondary Outcomes (2)

• Rate of Ovarian Dysfunction at 2 Years

  2 years

• Rate of Ovarian Dysfunction at 1 Year

  1 year

Other Outcomes (1)

• Ovarian Reserve at 1 and 2 Years

  1 and 2 years

Study Arms (2)

Standard Chemotherapy

ACTIVE COMPARATOR

Patients receive cyclophosphamide-containing chemotherapy alone.

Drug: cyclophosphamide

Chemotherapy Plus Goserelin

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.

Drug: cyclophosphamide; Drug: goserelin acetate

Interventions

cyclophosphamide DRUG

Part of planned chemotherapy regimen

Chemotherapy Plus Goserelin; Standard Chemotherapy

goserelin acetate DRUG

Given subcutaneously

Chemotherapy Plus Goserelin

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Cancer and Leukemia Group B: collaborator
• Eastern Cooperative Oncology Group: collaborator
• ETOP IBCSG Partners Foundation: collaborator

Study Sites (34)

Mater Hospital - North Sydney

North Sydney, New South Wales, 2060, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, 2298, Australia

Location

Royal Adelaide Hospital Cancer Centre

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Ballarat Oncology and Haematology Services

Ballarat, Victoria, 3350, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Monash Medical Center - Clayton Campus

Clayton, Victoria, 3168, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

Maroondah Hospital

East Ringwood, Victoria, 3135, Australia

Location

St. Vincent's Hospital - Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Centre Hospitalier Hutois

Huy, 4500, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Centre Hospitalier Regional de la Citadelle

Liège, 4000, Belgium

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

AZ Damiaan

Ostend, 8400, Belgium

Location

Centre Hospitalier Peltzer-La Tourelle

Verviers, B-4800, Belgium

Location

National Institute of Oncology

Budapest, 1122, Hungary

Location

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

Location

Ospedale degli Infermi - ASL 12

Biella, 13900, Italy

Location

Ospedale Civile Ramazzini

Carpi, 41012, Italy

Location

Ospedale Alessandro Manzoni

Lecco, 23900, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Auckland City Hospital

Auckland, 1, New Zealand

Location

Oncology Institute of Southern Switzerland

Bellinzona, CH-6500, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Oncology Institute of Southern Switzerland - Locarno

Locarno, CH-6601, Switzerland

Location

Oncology Institute of Southern Switzerland - Lugano

Lugano, CH-6900, Switzerland

Location

Oncology Institute of Southern Switzerland - Mendrisio

Mendrisio, CH-6850, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 25738668 DERIVED

Related Links

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

MeSH Terms

Conditions

Breast Neoplasms; Infertility

Interventions

Cyclophosphamide; Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Cancer Survivorship Committee Statistician
• Organization: SWOG Statistics and Data Management Center

206-667-4623

Study Officials

• Halle C Moore, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: October 1, 2003
• Primary Completion: January 1, 2014
• Study Completion: September 1, 2016
• Last Updated: December 30, 2019
• Results First Posted: April 4, 2017

Record last verified: 2019-12

Locations

HU (1); CH (7); BE (6); AU (14); NZ (1); IT (5)