Status:
COMPLETED
Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed to preliminarily estimate the efficacy and evaluate the safety and tolerability of onartuzumab (MetMAb) + b...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)-, and human epidermal growth factor 2 (HER2)-negative (triple-negative) adenocarcinoma of the breast
- Confirmed availability of tumor tissue
Exclusion
- Prior therapy with two or more regimens for metastatic breast cancer
- Any systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1
- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1
- Prior therapy with a taxane for metastatic breast cancer
- Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative vascular endothelial growth factor (VEGF) pathway-targeted therapy following diagnosis of breast cancer
- Prior therapy with hormones and/or trastuzumab
- Inadequate hematology, renal, or hepatic organ function
- Bevacizumab
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT01186991
Start Date
March 1 2011
End Date
March 1 2016
Last Update
January 20 2017
Active Locations (53)
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1
Comprehensive Blood/Cancer Ctr
Bakersfield, California, United States, 93309
2
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, United States, 92835
3
Can Care Assoc Med Group Inc; Beach Cities Offices
Los Angeles, California, United States, 90095-1772
4
Univ of California Los Angeles
Los Angeles, California, United States, 90095