Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer

• Time to Resumption of Menses [ Time Frame: Baseline, end of chemotherapy then 5 years ] [ Designated as safety issue: No ]
  Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years
  
  

• Chemotherapy-related Amenorrhea [ Time Frame: Baseline, end of chemotherapy then 5 years ] [ Designated as safety issue: No ]
  Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment. Record of menses is completed by patient throughout their time on study through chemotherapy and for 5 years.
  
  
• Alternative Markers of Ovarian Failure as Assessed by Inhibin A and Inhibin B Every 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years [ Time Frame: Baseline, end of chemotherapy then 5 years ] [ Designated as safety issue: No ]
  Inhibin A & inhibin B are collected at baseline, end of chemotherapy, then every 6 months for 2 years then annually for 3 more years. Inhibin A & Inhibin B are markers of ovarian failure.
  
  
• Quality of Life as Assessed by FACT-ES Monthly During Treatment, Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years [ Time Frame: Baseline, through chemotherapy then 5 years ] [ Designated as safety issue: No ]
  FACT-ES (v4/4a) quality of life validated tool combines 18 item endocrine subscale (ES) with standardized breast cancer quality of life measure. Administered monthly during treatment, every very 6 months beginning in month 6 for 2 years and then annually for 3 years.
  
  
• Disease-free Survival Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years [ Time Frame: 5 years after end of chemotherapy ] [ Designated as safety issue: No ]
  Every 6 months for 2 years then annual for 3 more years. Patients will be seen, laboratory specimens will be drawn. Menses records will be collected and reviewed. Concomitant medications will be updated.
  
  

OBJECTIVES:

Primary

• Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy.

Secondary

• Determine the rate of chemotherapy-related amenorrhea in patients treated with this drug.
• Determine the value of inhibin A and B as alternative markers of premature ovarian failure in patients treated with this drug.
• Determine quality of life of patients treated with this drug.
• Determine disease-free and overall survival of patients treated with this drug.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (< 35 years vs 35 to 39 years vs > 39 years); concurrent neoadjuvant or adjuvant systemic chemotherapy (fluorouracil, epirubicin, and cyclophosphamide [6 courses] OR fluorouracil, doxorubicin, and cyclophosphamide [6 courses] vs doxorubicin and cyclophosphamide [AC] [4 courses] vs doxorubicin and cyclophosphamide [AC] [4 courses] followed by a taxane [4 courses]); and hormone receptor status (estrogen receptor [ER]- AND progesterone receptor [PR]-negative vs ER- OR PR-positive).

• Arm I: Beginning within 1-4 weeks before the start of chemotherapy, patients receive triptorelin intramuscularly once monthly for 4-6 months during neoadjuvant or adjuvant systemic chemotherapy.
• Arm II: Patients receive neoadjuvant or adjuvant systemic chemotherapy only. Quality of life is assessed at baseline, monthly during treatment, every 6 months for 2 years, and then annually for 3 years.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 138 patients (69 per treatment arm) will be accrued for this study within 35 months.