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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
International Breast Cancer Study Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00068601
First received: September 10, 2003
Last updated: May 22, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Southwest Oncology Group:

Primary Outcome Measures:
  • Rate of premature ovarian failure at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of FSH in the post-menopausal range.


Secondary Outcome Measures:
  • Rate of ovarian dysfunction at 1 and 2 years [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
    Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.

  • Ovarian reserve at 1 and 2 years [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
    Measurements of ovarian reserve will consist of "Day 2 - 4" levels of FSH, estradiol and inhibin B during Month 12/13 and Month 24/25 (or if amenorrheic, anytime during Month 12/13 and Month 24/25).


Estimated Enrollment: 416
Study Start Date: October 2003
Estimated Study Completion Date: September 2016
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068601

  Hide Study Locations
Locations
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
Principal Investigator: Halle C Moore, MD The Cleveland Clinic
Study Chair: Kathy S. Albain, MD Loyola University
Study Chair: 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: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00068601     History of Changes
Obsolete Identifiers: NCT00696267
Other Study ID Numbers: CDR0000327758, S0230, CALGB-40401, IBCSG-34-05, U10CA037429
Study First Received: September 10, 2003
Last Updated: May 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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 July 20, 2014