A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.
PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
OBJECTIVES:
OUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Completely resected disease
No clinically detectable residual loco-regional axillary disease
Prior surgery for primary breast cancer of 1 of the following types:
Tumor confined to the breast and axillary nodes
Axillary lymph node dissection or a negative axillary sentinel node biopsy required
No distant metastases
No locally advanced inoperable breast cancer, including any of the following:
Bilateral synchronous invasive breast cancer allowed if disease meets all other eligibility criteria
No prior ipsilateral or contralateral invasive breast cancer
Hormone receptor status:
Estrogen and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Premenopausal
Estradiol in the premenopausal range after prior surgery OR meets the following criteria:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
Not pregnant or nursing
Fertile patients must use effective nonhormonal contraception
No history of noncompliance to medical regimens
No other nonmalignant systemic disease that would preclude prolonged follow-up
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of the following:
No psychiatric, addictive, or other disorder that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent bisphosphonates, except in the following cases:
No other concurrent investigational agents
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