Study of Anastrozole, Letrozole, or Exemestane With or Without Tamoxifen in Treating Postmenopausal Women With Hormone-Responsive Breast Cancer That Has Been Completely Removed By Surgery
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer completely removed by surgery
- Any T, any N
- No recurrent or metastatic disease
Estrogen or progesterone receptor-positive disease in primary tumor, as defined by 1 of the following:
- At least 10% of tumor cells positive by immunohistochemistry
- At least 10 fmol/mg cytosol protein by ligand binding assay
- Patients with HER-2/neu positive tumors are eligible provided they receive trastuzumab (Herceptin®) according to the registered schedule
PATIENT CHARACTERISTICS:
- Female
Postmenopausal, defined by ≥ 1 of the following:
- Age ≥ 60 years
Age 45-59 and satisfying 1 or more of the following criteria:
- Amenorrhea for ≥ 12 months AND intact uterus
- Amenorrhea (secondary to hysterectomy, hormone replacement therapy (HRT), or chemotherapy) for < 12 months AND follicle-stimulating hormone within the postmenopausal range
- Underwent prior bilateral oophorectomy at any age >18 years
- No concurrent illness that contraindicates adjuvant endocrine treatment
- No other invasive breast cancer or invasive malignancy within the past 10 years, except adequately cone-biopsied squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- No concurrent disease that would place the patient at unusual risk
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Adjuvant or neoadjuvant chemotherapy must be completed prior to study entry
- At least 1 month since prior and no concurrent HRT
- More than 30 days since prior systemic investigational drugs
- No prior tamoxifen as part of any breast cancer prevention study
- Prior or concurrent locoregional radiotherapy allowed
- No other concurrent experimental drugs
- No concurrent bisphosphonates, unless indicated as treatment for osteoporosis
Sites / Locations
- Federico II University Medical School
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Seconda Universita di Napoli
- Arcispedale S. Maria Nuova
- Istituti Fisioterapici Ospitalieri - Roma
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
A - anastrozole
B - exemestane
C - letrozole
D - tamoxifen followed by anastrozole
E - tamoxifen followed by exemestane
F - tamoxifen followed by letrozole
Up-front adjuvant anastrozole for 5 years
Up-front adjuvant exemestane for 5 years
Up-front adjuvant letrozole for 5 years
Switch adjuvant treatment with tamoxifen for 2 years followed by anastrozole for 3 years
Switch adjuvant treatment with tamoxifen for 2 years followed by exemestane for 3 years
Switch adjuvant treatment with tamoxifen for 2 years followed by letrozolefor 3 years