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

Inclusion Criteria

• •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