Status:
UNKNOWN
Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study
Lead Sponsor:
Chap, Linnea I., M.D.
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 w...
Detailed Description
Approximately 200,000 women are diagnosed with breast cancer in the United States every year. A significant factor determining long-term survivability of breast cancer is whether or not lymph nodes, g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00378638
Start Date
June 1 2006
End Date
October 1 2008
Last Update
October 24 2007
Active Locations (1)
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1
Premiere Oncology
Santa Monica, California, United States, 90404