Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed infiltrating breast adenocarcinoma
• * Large, operable tumor
• * Stage T2 (≥ 3 cm) or T3-T4 (excluding inflammatory disease), N0-N3, M0 disease
• * No bilateral inflammatory breast tumors (T4d \[PEV-2 or PEV-3\])
• * Elston-Ellis grade I or II and mitotic index 1 or 2 (if \< 65 years of age)
• At least 1 embedded and 1 frozen biopsy sample available
• No multifocal or multicentric tumors for which breast conservation cannot be envisaged
• No ErbB2-overexpressing tumors (HER2 3+ by IHC OR HER2 2+ by IHC and FISH positive)
• Hormone receptor status:
• * Estrogen receptor and/or progesterone receptor positive tumor (\> 10%) as assessed by IHC
• PATIENT CHARACTERISTICS:
• Female
• Postmenopausal
• ECOG performance status 0-2
• ANC ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Total bilirubin ≤ 1.25 times ULN
• AST and ALT ≤ 1.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• No other cancer within the past 10 years, except basal cell skin cancer or previously treated carcinoma in situ of the cervix
• No uncontrolled cardiac pathology, including any of the following:
• * Angina pectoris
• * Congestive cardiac insufficiency
• * Myocardial infarction within the past 3 months
• No known history of hemorrhagic diathesis
• No known allergy to the study drugs or their excipients
• No congenital galactosemia, glucose malabsorption syndrome, or lactase deficiency
• No chronic somatic or psychiatric illness with pejorative prognosis
• No geographical, social, or psychiatric condition that would preclude study compliance and follow-up schedule
• No individual deprived of liberty or placed under the authority of a tutor
• PRIOR CONCURRENT THERAPY:
• No prior chemotherapy, hormonal therapy, or any targeted treatment for the breast tumor
• At least 2 weeks since prior hormone replacement therapy for menopause
• No concurrent long-term anticoagulation treatment
• No concurrent participation on another therapeutic trial involving an experimental molecule