Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening.

PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early menopause in premenopausal women who are receiving chemotherapy for stage I, stage II, or stage III breast cancer that has been removed by surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Mammella (GIM)
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Fluorouracil; Liposomal doxorubicin; Methotrexate; Paclitaxel; Triptorelin Pamoate

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed breast cancer resected at time of original diagnosis

• Stage I-III disease

• Candidate for 1 of the following adjuvant chemotherapy regimens:

• FEC (fluorouracil, epirubicin hydrochloride, and cyclophosphamide) every 21 or 28 days

• CMF (cyclophosphamide, methotrexate, and fluorouracil) every 28 days

• A→CMF (doxorubicin hydrochloride followed by CMF)

• EC→P (epirubicin hydrochloride and cyclophosphamide every 21 days followed by paclitaxel every 21 days)

• FEC→P (FEC every 21 days followed by paclitaxel every 21 days)

• EC→D (EC every 21 days followed by docetaxel every 21 days)

• AC (doxorubicin hydrochloride and cyclophosphamide) every 21 days

• AC→P (AC every 21 days followed by paclitaxel every 21 days)

• E→CMF (epirubicin hydrochloride followed by CMF every 28 days)

• No evidence of metastases or localized or distant recurrence

• Investigation to exclude metastases required for any suspicious manifestation

• Premenopausal, defined as the presence of active menstrual cycles or normal menses within six weeks before initiation of chemotherapy

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Female

• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or adequately treated in situ carcinoma of the cervix

• No history of noncompliance to medical regimens or patients who are considered potentially unreliable

• Not pregnant or nursing

• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy and/or radiotherapy for cancer or non-neoplastic disease

• No other concurrent hormonal therapy except for tamoxifen