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

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. 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.

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

Conditions

• Breast Cancer
• Hot Flashes
• Menopausal Symptoms
• Osteoporosis
• Sexual Dysfunction and Infertility

Study Type

Interventional

Study Design

Supportive Care, Randomized, Active Control

Further Details

Primary Outcome Measures:

• Rate of premature ovarian failure at 2 years

Secondary Outcome Measures:

• Rate of ovarian dysfunction at 1 and 2 years
• Ovarian reserve at 1 and 2 years

OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3-month/4-course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.

1. 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.
2. Patients receive cyclophosphamide-containing chemotherapy alone. Patients are followed at 1, 2, and 5 years.

Study Start

October 2003

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 49 Years
• Genders Eligible for Study: Female

Inclusion Criteria:

• 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
• Menopausal status: Premenopausal
• Performance status: Zubrod 0-2
• 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
• No prior cytotoxic chemotherapy
• No other concurrent hormonal therapy
• Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed
• Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed

Total Enrolment

416

Contact Details

Peter MacCallum Cancer Centre, East Melbourne, Victoria, 3002, Australia; Recruiting

• Kelly-Anne Phillips 613-9656-1701
• For more information, see The National Cancer Institute