Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer
Completed · Phase 2 · Has a placebo group
Conditions studied: Breast Cancer
In brief
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) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus placebo + bevacizumab + paclitaxel in participants with metastatic or locally recurrent, triple-negative breast cancer who either have not received treatment (first-line) or have progressed after one conventional cytotoxic chemotherapy regimen (second-line).
Key facts
- Study ID
- NCT01186991
- Run by
- Genentech, Inc.
- People needed
- 185
- Starts
- 2011-03-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2017-01-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 Exclusion Criteria:
- Uncontrolled hypertension (systolic pressure greater than [>] 150 millimeters of mercury [mmHg] and/or diastolic pressure > 100 mmHg), with or without anti-hypertensive medication
- Evidence of bleeding diathesis or coagulopathy
Where it is running
- St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr — Fullerton, California, United States
- Can Care Assoc Med Group Inc; Beach Cities Offices — Los Angeles, California, United States
- Univ of California Los Angeles — Los Angeles, California, United States
- Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States
- Sharp Healthcare; Oncology Research Program — San Diego, California, United States
- Kaiser Permanente - Vallejo — Vallejo, California, United States
- Holy Cross Hospital — Fort Lauderdale, Florida, United States
- Florida Cancer Specialists; SCRI — Fort Myers, Florida, United States
- Suburban Hematology Oncology — Lawrenceville, Georgia, United States
- Cancer Center of Kansas — Wichita, Kansas, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Karmanos Cancer Institute.. — Detroit, Michigan, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- North Shore Hem Onc Associates — East Setauket, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
- Charleston Hematology Oncology — Charleston, South Carolina, United States
- South Carolina Onc. Associate — Columbia, South Carolina, United States
- SCRI Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States
- The Sarah Cannon Research Inst — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Northern Utah Associates — Ogden, Utah, United States
- Institut Jules Bordet — Brussels, Belgium
- UZ Antwerpen — Edegem, Belgium
- Comprehensive Blood/Cancer Ctr — Bakersfield, California, United States
Full record on ClinicalTrials.gov
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