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

Launched by CHAP, LINNEA I., M.D. · Sep 18, 2006

Keywords

ClinConnect Summary

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, glands which cleanse and filter the body's fluids, are involved. Despite treatment with approved multiagent cytotoxic chemotherapy ("dose-dense chemotherapy"), women with breast cancer involving more than 4 axillary lymph nodes still have a high risk for recurrence.

Several dose-dense chemotherapy regimens are currently being compared in other studies, however, at this time there is no proof th...

Gender

FEMALE

Eligibility 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