Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer

NCT ID: NCT00461773

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-05-31

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 sensitive breast cancer.

Conditions

Hormone-Sensitive Breast Cancer; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bevacizumab

brief exposure bevacizumab

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

bevacizumab 10 mg/kg IV

bevacizumab and letrozole

brief exposure bevacizumab and letrozole

Group Type: ACTIVE_COMPARATOR

Letrozole

Intervention Type: DRUG

Letrozole 2.5 mg po qd

Bevacizumab

Intervention Type: DRUG

bevacizumab 10 mg/kg IV

Interventions

Letrozole

Letrozole 2.5 mg po qd

Intervention Type: DRUG

Bevacizumab

bevacizumab 10 mg/kg IV

Intervention Type: DRUG

Other Intervention Names

Femara; Avastin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gina Chung, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University, Yale Cancer Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0609001793

Identifier Type: -

Identifier Source: org_study_id