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

Status unconfirmed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00378638

Run by

Chap, Linnea I., M.D.

People needed

30

Starts

2006-06-01

Expected to finish

2008-10-01

Last updated by the study team

2007-10-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Premiere Oncology — Santa Monica, California, United States (enrolling)

Full record on ClinicalTrials.gov

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