Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer
This trial is active, not recruiting.
|Conditions||breast cancer, cancer of the breast, breast neoplasm|
|Treatments||letrozole (femara), letrozole; avastin|
|Sponsor||University of Alabama at Birmingham|
|Start date||October 2007|
|End date||September 2016|
|Trial size||75 participants|
|Trial identifier||NCT00530868, F061229006, UAB 0648|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Birmingham, AL||University of Alabama at Birmingham||no longer recruiting|
|San Francisco, CA||University of California, San Francisco Comprehensive Cancer Center||no longer recruiting|
|Washington, DC||Georgetown University Medical Center||no longer recruiting|
|Atlanta, GA||Georgia Cancer Specialists||no longer recruiting|
|Chicago, IL||University of Chicago Medical Center||no longer recruiting|
|Boston, MA||Dana Farber Cancer Institute||no longer recruiting|
|Chapel Hill, NC||University of of North Carolina at Chapel Hill||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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.
time frame: 24 weeks
Clinical objective response; tolerability and toxicity; biomarkers for prognostic value.
time frame: 24 weeks
Male or female participants at least 19 years old.
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.
|Official title||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|
|Principal investigator||Andres Forero, M.D.|
|Description||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.|
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