A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women With Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy
- Compare ovarian function suppression and tamoxifen or exemestane with vs without
adjuvant chemotherapy in premenopausal women with endocrine-responsive resected breast
- Compare the disease-free and overall survival of patients treated with these regimens.
- Compare sites of first treatment failure in patients treated with these regimens.
- Compare the incidence of second nonbreast malignancies in patients treated with these
- Compare the quality of life, including late side effects of early menopause, of
patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, number of positive axillary and/or internal mammary lymph nodes (0 vs
1 or more), method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian
irradiation), chemotherapy if randomized to arm II (not containing vs containing an
anthracycline or taxane), and endocrine agent (tamoxifen vs exemestane vs selected by
subsequent randomization in the TEXT trial). Patients are randomized to 1 of 2 treatment
- Arm I: Patients receive ovarian function suppression comprising triptorelin
intramuscularly on day 1 every 28 days for 5 years, oophorectomy, or ovarian
irradiation. Beginning when ovarian function has been suppressed, patients also receive
oral tamoxifen or exemestane once daily for 5 years in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive ovarian function suppression as in arm I and concurrent
chemotherapy for at least 2 months (if an anthracycline is included) or at least 4
months (if no anthracycline is included). Beginning after the completion of
chemotherapy or when ovarian function has been suppressed, patients also receive oral
tamoxifen or exemestane as in arm I.
Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4
Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then
PROJECTED ACCRUAL: A total of 1,750 patients will be accrued for this study within 7 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Relapse (i.e., local, regional, or distant)
7 years after inclusion of last patient
Rosalba Torrisi, MD
European Institute of Oncology
Australia: Department of Health and Ageing Therapeutic Goods Administration