Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study

• Status: Unknown status
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This research focuses on women with breast cancer whose disease has not significantly progressed, but who have 5 or more lymph nodes involved. In this study subjects will receive bevacizumab, a drug which is FDA approved for colon cancer but not for breast cancer, in combination with a regimen of approved chemotherapy drugs known as "dose dense chemotherapy." The study will observe the effectiveness and tolerability of this regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chap, Linnea I., M.D.
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• High risk lymph node positive breast cancer defined as 5 or more involved axillary lymph nodes

• Must have undergone surgical local therapy (modified radical mastectomy or breast conserving surgery).

• Negative tumor margins for invasive cancer

• No evidence of distant metastasis

• Normal cardiac ejection fraction

• Adequate organ function defined as:

ANC > 1200/mm3 Platelet count > 100,000/mm Serum creatinine < 2.0 mg/dl Serum bilirubin < 1.5 x ULN

• Performance status 0-1

• Age 18 years or older

• No prior chemotherapy, hormonal therapy or radiation therapy for treatment of the primary breast cancer

• Bilateral synchronous breast cancer is allowed if other criteria are met.

• Patients may be ER/PR+ and receive treatment with hormonal therapy (tamoxifen or aromatase inhibitors)

• Use of effective means of contraception (men and women) in subjects of child-bearing potential

• Signed informed consent

Exclusion Criteria:

• Evidence of distant metastases

• Inflammatory Breast Cancer

• Prior use of any chemotherapy or hormonal therapy for breast cancer

• Patients with her 2 neu positive tumors

• History of other malignancies within the last 5 years. Prior history of carcinoma in situ of the cervix, melanoma in situ and basal cell carcinoma of the skin is allowed within the last 5 years.

• Prior therapy with anthracyclines for any malignancy

• 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

• Blood pressure of equal to or higher than 150/100

• Unstable angina

• New York Heart Association (NYHA) Grade II or greater congestive heart failure

• History of myocardial infarction within 6 months

• History of stroke within 6 months

• Clinically significant peripheral vascular disease

• Evidence of bleeding diathesis or coagulopathy

• 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 such as fine needle aspirations or core biopsies within 7 days prior to Day 0

• Pregnant (positive pregnancy test) or lactating

• Urine protein:creatinine ratio >1.0 at screening

• 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

• Inability to comply with study and/or follow-up procedures