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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:3/2/2019
Start Date:October 2007
End Date:January 2020

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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

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.

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
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.
We found this trial at
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Atlanta, Georgia 30341
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Chapel Hill, North Carolina 27599
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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