Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer
Condition: Breast Cancer; Cancer of the Breast; Breast Neoplasm
MeSH terms: Breast Neoplasms
Intervention: Letrozole (Femara); Letrozole; Avastin
Intervention description: Letrozole 2.5 mg PO a day for 24 weeks; Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks
Intervention MeSH terms: Bevacizumab; Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Hormonal and antibody therapy for breast cancer; Hormonal therapy for breast cancer; Antibody therapy for breast cancer

Summary:

      This purpose of this trial is to show that the combination of Avastin and hormone therapy
      should be more effective than hormone therapy alone for the treatment of breast cancer.
    

Eligibility criteria:

        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.