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: September 18, 2014
Last verified: September 2014

September 10, 2003
September 18, 2014
October 2003
January 2014   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00068601 on ClinicalTrials.gov Archive Site
  • 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).
Not Provided
Not Provided
Not Provided
 
S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Infertility
  • Menopausal Symptoms
  • Drug: cyclophosphamide
    Part of planned chemotherapy regimen
  • Drug: goserelin acetate
    Given subcutaneously
  • 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.
    Interventions:
    • Drug: cyclophosphamide
    • Drug: goserelin acetate
  • Active Comparator: Arm II
    Patients receive cyclophosphamide-containing chemotherapy alone.
    Intervention: Drug: cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
416
September 2016
January 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Hungary,   Italy,   New Zealand,   Switzerland
 
NCT00068601
CDR0000327758, S0230, CALGB-40401, IBCSG-34-05, U10CA037429
Yes
Southwest Oncology Group
Southwest Oncology Group
  • National Cancer Institute (NCI)
  • Cancer and Leukemia Group B
  • Eastern Cooperative Oncology Group
  • International Breast Cancer Study Group
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
Southwest Oncology Group
September 2014

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