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

Anglo Celtic Cooperative Oncology Group

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Infertility; Menopausal Symptoms

Treatments: Procedure: fertility assessment and management; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Drug: cyclophosphamide; Drug: goserelin acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT00427245

CRUK-OPTION

ISRCTN84856516

CDR0000526368 (Registry Identifier)

EU-20680

CRUK-BR0402

EUDRACT-2004-000133-11

Details and patient eligibility

About

RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer.

PURPOSE: This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I, stage II, or stage III breast cancer.

Full description

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.

Enrollment: 400 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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