Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer

Inclusion Criteria:

All patients must meet the following criteria to be eligible for study entry:

• Pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast, T2-T3 / T4a-c / N0-2 / M0, with positive estrogen and/or progesterone receptors, and Her-2-neu negative. Patients with inflammatory breast cancer will not be included (T4d). Patients previously treated patients with no measurable disease or patients with metastatic disease will be excluded.
• Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

• Patients must be postmenopausal, defined as one of the following:

  • Patients > 50 years of age with no spontaneous menses for at least 12 months,
  • Bilateral oophorectomy
• Be ambulatory (outpatient) and have an ECOG PS <1.
• Patients must have measurable disease by mammogram and/or breast ultrasound (in special cases a dedicated breast MRI may be clinically indicated). The target lesion must not have been previously irradiated.
• No prior chemotherapy.
• Patients must have adequate organ and marrow function as defined as follows: absolute neutrophil count > 1,500/mm3, hemoglobin > 8.0 g/dl, platelets > 75,000/mm3, total bilirubin < 2 mg/dl, serum creatinine < 2 mg/dl, Transaminases (AST, ALT) may be up to 2 x institutional upper limit of normal. In addition < 1 gr of protein in 24 hr urine collection and urine protein/creatinine ratio < 1.0.
• No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy.
• Hypertension must be controlled (<150/100 mmHg).
• Ejection Fraction > 50% by echocardiogram. (LVEF greater than 75% at baseline should be reviewed and/or the test repeated as it may be falsely elevated).
• No history of thrombosis during the previous 12 months.

Exclusion Criteria:

• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than this sponsor-investigator Bevacizumab cancer study.
• Uncontrolled high blood pressure (>150/100 mmHg).
• Unstable angina
• New York Heart Association (NYHA) Grade III or greater congestive heart failure
• History of myocardial infarction or unstable angina within 12 months
• History of stroke or TIA within 12 months
• Clinically significant peripheral vascular disease
• History of a bleeding disorder
• Presence of central nervous system or brain metastases
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
• Minor surgical procedures (excluding fine needle aspirations or core biopsies) within 5 days prior to Day 0
• Pregnant (positive pregnancy test) or lactating
• Urine protein: creatinine ratio greater than or equal to 1.0 at screening or patients demonstrating > 1 gr of protein in 24 hr urine collection within 4 weeks prior to study entry will not participate in the trial.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
• Serious, non-healing wound, ulcer, or bone fracture
• Unwilling or unable to comply with the protocol for the duration of the study.
• Psychiatric illness/social situations that would limit compliance with study requirements.
• History of another malignancy within the last five years except non-melanoma skin cancer and carcinoma in-situ of uterine cervix.
• Patients with metastatic disease.