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A Phase II Open Label Trial of Pre-Operative (Neoadjuvant) Letrozole in Combination With Bevacizumab in Post-Menopausal Women With Newly Diagnosed Operable Breast Cancer

Phase 2
60 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase II Open Label Trial of Pre-Operative (Neoadjuvant) Letrozole in Combination With Bevacizumab in Post-Menopausal Women With Newly Diagnosed Operable Breast Cancer

This is an open label, single arm, and Phase II study of the combination of Letrozole and
Bevacizumab in patients with newly diagnosed breast cancer. Patients meeting the
eligibility criteria and who have signed the consent form will start Letrozole 2.5 mg by
mouth a day and Bevacizumab 15 mg per Kg IV every 3 weeks for 18 weeks (24 weeks if still
responding at week 18 if approved by the PI). After neoadjuvant therapy, participants will
undergo surgical treatment and will receive adjuvant therapy according to the treating

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective is to estimate the pathological complete response rate of neoadjuvant therapy in operable newly diagnosed ER+ breast cancer patients using the combination of Avastin and Letrozole.

Outcome Time Frame:

approximately 24 weeks

Safety Issue:


Principal Investigator

Andres Forero-Torres, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:




Start Date:

June 2005

Completion Date:

November 2006

Related Keywords:

  • Breast Cancer
  • Carcinoma of the breast
  • Breast cancer
  • Breast Neoplasms



University of Alabama at Birmingham Birmingham, Alabama  35294-3300