Clinical trial NCT00161291 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: letrozole in combination with bevacizumab
SMILES: N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N
Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of
             the breast, T2-T4 / T4a-c / N0-2 / M0, with positive estrogen and/or progesterone
             receptors. Patients with inflammatory breast cancer will not be included (Stage IIIb).
             Patients previously treated patients with no measurable disease or patients with
             metastatic disease will be excluded.

          -  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 (see Appendix B - consent form).

          -  Females 60 years of age (postmenopausal).

          -  Be ambulatory (outpatient) and have an ECOG PS <2 (Appendix F).

          -  Patients must have measurable disease by mammogram and/or breast ultrasound. 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
             2.0 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%.

          -  No history of thrombosis during the previous year.

        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 II or greater congestive heart failure see
             Appendix G)

          -  History of myocardial infarction within 6 months

          -  History of stroke within 6 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, fine needle aspirations or core biopsies within 7 days
             prior to Day 0

          -  Pregnant (positive pregnancy test) or lactating

          -  Urine protein: creatinine ratio 1.0 at screening. 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 cured basal cell
             carcinoma of skin and carcinoma in-situ of uterine cervix.

          -  Patients with metastatic disease.