Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer.

Eligibility Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease

• Signed Informed Consent Form

• Age >/= 18 years

• For women of childbearing potential, use of accepted and effective method of non-hormonal contraception

• ECOG performance status of 0 or 1

• Ability and capacity to comply with study and follow-up procedures

• For anthracycline cohort only: adequate left ventricular function at study entry, defined as an LVEF >/= 50% by either MUGA scan or ECHO.

• For subjects who have received recent radiation therapy: recovery prior to Day 0 from any significant (Grade >/= 3) acute toxicity

Exclusion Criteria:

• Unknown HER2 status or known HER2-positive status

• Prior chemotherapy for locally recurrent or metastatic disease

• Prior hormonal therapy less than 1 week prior to Day 0

• Prior adjuvant or neoadjuvant chemotherapy within 12 months prior to Day 0

• For anthracycline cohort only: Prior anthracycline as part of neoadjuvant or adjuvant therapy for localized breast cancer

• Investigational therapy within 28 days of Day 0

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or 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

• Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy

• Known brain or other CNS metastases

• Blood pressure of > 150/100 mm Hg

• Unstable angina

• New York Heart Association (NYHA) Grade II or greater CHF

• History of myocardial infarction within 6 months prior to Day 0

• History of stroke or transient ischemic attack within 6 months prior to Day 0

• Clinically significant peripheral vascular disease

• Evidence of bleeding diathesis or coagulopathy

• 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

• Pregnancy (positive serum pregnancy test) or lactation

• Inadequate organ function, as evidenced by any of the following laboratory values: Absolute neutrophil count < 1500/uL; Platelet count < 100,000/uL; Total bilirubin > 1.5 mg/dL; Alkaline phosphatase, AST, and/or ALT > 2x upper limit of normal (> 5x ULN in subjects with known liver or, for alkaline phosphatase elevations, bone involvement); Alkaline phosphatase > 2x ULN (> 7x ULN in subjects with known bone involvement); Serum creatinine > 2.0 mg/dL; PTT and/or either INR or PT > 1.5x upper limit of normal (except for subjects receiving anti-coagulation therapy); Urine protein/creatinine ratio > 1.0 at screening for U.S. subjects, or urine dipstick for proteinuria >/= 1+ at screening followed by 24-hour urine collection demonstrating > 1 g protein/24 hr for ex-U.S. subjects

• Uncontrolled serious medical or psychiatric illness

• Active infection requiring intravenous (IV) antibiotics at Day 0

• History of other malignancies within 5 years of Day 0 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix (subjects with a history of bilateral breast cancer will be eligible)

Trial Contact Information

Trial Lead Organizations/Sponsors

Genentech Incorporated

Leonardo Faoro, M.D.

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00262067
Information obtained from ClinicalTrials.gov on April 29, 2013

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