Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer

OBJECTIVES:

Primary

• Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin .

Secondary

• Compare the quality of life of patients treated with these regimens.
• Compare menopausal symptoms in patients treated with these regimens.
• Compare bone mineral density loss in patients treated with these regimens.
• Compare hormone levels in patients treated with these regimens.
• Compare menstruation in patients treated with these regimens.
• Compare the incidence of pregnancy in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, prospective, parallel group, multicenter study. Patients are stratified according to age (≤ 40 years vs > 40 years) and participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I (chemotherapy alone): Patients receive neoadjuvant or adjuvant cyclophosphamide- and/or anthracycline-containing chemotherapy. Treatment continues for 6-8 courses in the absence of disease progression or unacceptable toxicity.

Arm II (chemotherapy plus goserelin for ovarian function suppression): Patients receive neoadjuvant or adjuvant chemotherapy as in arm I. Patients also receive goserelin subcutaneously every 3-4 weeks beginning 1-3 weeks before the start of chemotherapy. Treatment with goserelin repeats every 3-4 weeks until completion of chemotherapy.

Quality of life is assessed at baseline, at 3, 6, 12, 18, and 24 months, and then annually for up to 5 years.

After completion of study therapy, patients are followed periodically for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Stages I-IIIB with node-positive or -negative disease (N0-2)
• Operable disease
• Must meet 1 of the following criteria:

• Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks
• Scheduled to receive neoadjuvant chemotherapy
• No metastatic breast cancer, including supraclavicular fossa metastases
• Hormone receptor status meeting 1 of the following criteria:

• Estrogen receptor (ER) and progesterone receptor poor or negative AND not a candidate for adjuvant endocrine therapy
• ER positive AND no requirement for ovarian suppression as a necessary part of treatment

PATIENT CHARACTERISTICS:

• Female
• Premenopausal with regular menses in the 12 months preceding surgery
• No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• Suitable fitness status for chemotherapy
• Adequate hepatic, renal, and bone marrow function
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy or endocrine therapy