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A Phase II, Randomized, Open Label Trial of Pre-operative (Neoadjuvant)Letrozole (Femara) vs. Letrozole in Combination With Avastin in Post Menopausal Women With Newly Diagnosed Operable Breast Cancer

Phase 2
19 Years
Open (Enrolling)
Breast Cancer, Cancer of the Breast, Breast Neoplasm

Thank you

Trial Information

A Phase II, Randomized, Open Label Trial of Pre-operative (Neoadjuvant)Letrozole (Femara) vs. Letrozole in Combination With Avastin in Post Menopausal Women With Newly Diagnosed Operable Breast Cancer

Preclinical and clinical data have demonstrated that up-regulation of tumor cell VEGF is an
important mechanism to subvert estrogen dependence in hormone responsive breast cancer
resulting in reduced therapy response or tumor resistance to hormonal therapy; thus, it is
hypothesized that the combination of an anti-VEGF agent (Avastin, an anti-VEGF monoclonal
antibody) and hormonal therapy should be more effective than hormonal therapy alone for the
treatment of 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response is defined as no evidence of residual invasive tumor in the breast or axillary lymph nodes or only residual ductal carcinoma in-situ.

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Andres Forero, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • Cancer of the Breast
  • Breast Neoplasm
  • Hormonal and antibody therapy for breast cancer
  • Hormonal therapy for breast cancer
  • Antibody therapy for breast cancer
  • Breast Neoplasms
  • Neoplasms



Georgia Cancer Specialists Decatur, Georgia  30033
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
University of Chicago Medical Center Chicago, Illinois  60637
Dana Farber Cancer Institute Boston, Massachusetts  02115
Georgetown University Medical Center Washington, District of Columbia  20007
University of California, San Francisco Comprehensive Cancer Center San Francisco, California  94143-1770
University of of North Carolina at Chapel Hill Chapel Hill, North Carolina  27599-7600