Preservation of Ovarian Function in Young Women Treated With (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the Gonadotropin-releasing Hormone (GnRH) Agonist (Triptorelin) During Chemotherapy
- 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.
- Determine the rate of chemotherapy-related amenorrhea in patients treated with this
- 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
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Time to Resumption of Menses
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
Baseline, end of chemotherapy then 5 years
Pamela N. Munster, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|CCOP - MeritCare Hospital||Fargo, North Dakota 58122|
|CCOP - Bay Area Tumor Institute||Oakland, California 94609-3305|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|CCOP - Northwest||Tacoma, Washington 98405-0986|
|Hulston Cancer Center at Cox Medical Center South||Springfield, Missouri 65807|
|MBCCOP - Medical College of Georgia Cancer Center||Augusta, Georgia 30912-3730|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida||Tampa, Florida 33612|
|MBCCOP - JHS Hospital of Cook County||Chicago, Illinois 60612|