View Clinical Trial (Medical Research Study)
Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06520 |
| Conditions: |
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Hormone-Sensitive Breast Cancer - Breast Cancer |
| Purpose: |
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The purpose of this study is to evaluate the objective response rate of a combination of
letrozole (Femara) and bevacizumab (Avastin) given preoperatively to postmenopausal patients
with hormone sensitive breast cancer.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Histologically confirmed operable or potentially operable invasive breast
adenocarcinoma that is clinically palpable and measurable
- Age ≥ 18 years
- Clinical Stage T2-4, N0-3, M0 (Stage II-III)
- Postmenopausal defined as Age ≥ 60 years and/or Age >45 years with amenorrhea 12
months with an intact uterus and/or History of bilateral oophorectomy and/or FSH and
estradiol levels in postmenopausal range
- ECOG PS 0, 1
- Unifocal disease
- ER and/or PR positive
- Adequate hematological, renal, and hepatic functions Absolute neutrophil count ≥
1,500/µL Platelet count ≥ 100,000/µL creatinine ≤ 1.5 mg/dL Serum total bilirubin ≤
1.5 mg/dL Alkaline phosphatase ≤ 3X the ULN for the reference lab SGOT/SGPT ≤ 3X the
ULN for the reference lab
- Patients or their legal representatives must be able to read, understand and provide
informed consent to participate in the trial
- Use of effective means of contraception (men and women) in subjects of child-bearing
potential
Exclusion Criteria:
- Prior history of and/or therapy for invasive breast cancer (includes chemotherapy,
radiation, hormonal therapy including AIs, tamoxifen, raloxifene, fulvestrant or any
other antiestrogen/SERM)
- Clinically significant cardiovascular disease, EF <50%
- Known CNS disease
- History of deep vein thrombosis or pulmonary embolism
- Proteinuria at screening as demonstrated by either Urine protein:creatinine (UPC)
ratio ≥ 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered
to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour
urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
- Presence of non-healing wound or fracture
- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study other than a Genentech-sponsored
bevacizumab cancer study
- Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or
diastolic blood pressure > 100 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
Appendix E)
- History of myocardial infarction or unstable angina within 12 months prior to study
enrollment
- Any history of stroke or transient ischemic attack at any time
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0
- Core biopsy or other minor surgical procedures such as fine needle aspirations or
core biopsies within 7 days prior to Day 0
- Pregnant (positive pregnancy test) or lactating. Use of effective means of
contraception (men and women) in subjects of child-bearing potential is mandatory
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0
- Known hypersensitivity to any component of bevacizumab or letrozole
- Inability to comply with study and/or follow-up procedures
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| NCT ID: |
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NCT00461773 |
| Primary Contact: |
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Principal Investigator
Gina Chung, M.D.
Yale University
Jeannie Kluytenaar, RN
Phone: 203-785-6523
Email: jeannie.kluytenaar@yale.edu
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| Backup Contact: |
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Email: Michele.alguard@yale.edu
Michele Alguard
Phone: 203-737-5908
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| Location Contact: |
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New Haven, Connecticut 06520
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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