Status:
TERMINATED
Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer
Lead Sponsor:
Yale University
Collaborating Sponsors:
Novartis
Genentech, Inc.
Conditions:
Hormone-Sensitive Breast Cancer
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 sensi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00461773
Start Date
March 1 2007
End Date
May 1 2010
Last Update
March 16 2021
Active Locations (1)
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1
Yale University, Yale Cancer Center
New Haven, Connecticut, United States, 06520