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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00068601
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : April 4, 2017
Last Update Posted : December 30, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
International Breast Cancer Study Group
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date  ICMJE September 10, 2003
First Posted Date  ICMJE September 11, 2003
Results First Submitted Date  ICMJE December 16, 2016
Results First Posted Date  ICMJE April 4, 2017
Last Update Posted Date December 30, 2019
Study Start Date  ICMJE October 2003
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
Rate of Premature Ovarian Failure at 2 Years [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • Rate of Ovarian Dysfunction at 2 Years [ Time Frame: 2 years ]
    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.
  • Rate of Ovarian Dysfunction at 1 Year [ Time Frame: 1 year ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: February 15, 2017)
Ovarian Reserve at 1 and 2 Years [ Time Frame: 1 and 2 years ]
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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
Official Title  ICMJE Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Infertility
  • Menopausal Symptoms
Intervention  ICMJE
  • Drug: cyclophosphamide
    Part of planned chemotherapy regimen
  • Drug: goserelin acetate
    Given subcutaneously
Study Arms  ICMJE
  • Active Comparator: Standard Chemotherapy
    Patients receive cyclophosphamide-containing chemotherapy alone.
    Intervention: Drug: cyclophosphamide
  • Experimental: 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.
    Interventions:
    • Drug: cyclophosphamide
    • Drug: goserelin acetate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2016)
257
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Hungary,   Italy,   New Zealand,   Switzerland
Removed Location Countries Peru,   Saudi Arabia,   United States
 
Administrative Information
NCT Number  ICMJE NCT00068601
Other Study ID Numbers  ICMJE CDR0000327758
S0230 ( Other Identifier: SWOG )
CALGB-40401 ( Other Identifier: CALGB )
IBCSG-34-05 ( Other Identifier: IBCSG )
U10CA037429 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor  ICMJE Southwest Oncology Group
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Cancer and Leukemia Group B
  • Eastern Cooperative Oncology Group
  • International Breast Cancer Study Group
Investigators  ICMJE
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
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
PRS Account Southwest Oncology Group
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP