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Completed

NCT Number: NCT00068601

S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Genital Diseases Infertility Menopausal Symptoms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mater Hospital - North Sydney, North Sydney, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

Part of planned chemotherapy regimen

Goserelin acetate

Drug

Given subcutaneously

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • Cancer and Leukemia Group B
  • ETOP IBCSG Partners Foundation
  • Eastern Cooperative Oncology Group
  • National Cancer Institute (NCI)

Registry information

Official study title

Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

Important dates

Study start
2003
Primary completion
2014
Study completion
2016
First posted
Sep 11, 2003
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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