Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer
A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple-Negative Breast Cancer
3 other identifiers
interventional
185
6 countries
53
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) + 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Mar 2011
Typical duration for phase_2 breast-cancer
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2010
CompletedFirst Posted
Study publicly available on registry
August 23, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJanuary 20, 2017
January 1, 2017
5 years
August 9, 2010
January 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants Who Have not Received Prior Systemic Therapy or Have Progressed to Prior First-line Treatment
From randomization until disease progression (PD), relapse, or death on study (within 30 days of last study drug administration) from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)
Secondary Outcomes (8)
PFS According to RECIST v1.1 in Participants Who Have not Received Prior Systemic Therapy
From randomization until PD, relapse, or death on study from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)
Percentage of Participants With Objective Response as Assessed by the Investigator According to RECIST v1.1
From randomization until PD, relapse, or death on study from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)
Duration of Response as Assessed by the Investigator Using RECIST v1.1
From initial objective response to PD or death on study from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)
Overall Survival (OS)
From randomization until death from any cause, loss to follow-up, study termination by sponsor, or participant's withdrawal in survival follow-up (overall up to 5 years)
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)
Day 1 Cycle 1 (cycle length=28 days) up to 30 days after last dose of study drug or study discontinuation/termination, whichever is later (overall up to 5 years)
- +3 more secondary outcomes
Study Arms (3)
Onartuzumab + Bevacizumab + Paclitaxel
EXPERIMENTALParticipants will receive treatment with onartuzumab, bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable drug-related toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).
Onartuzumab + Placebo + Paclitaxel
EXPERIMENTALParticipants will receive treatment with onartuzumab, placebo matching to bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).
Placebo + Bevacizumab + Paclitaxel
ACTIVE COMPARATORParticipants will receive treatment with placebo matching to onartuzumab, bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).
Interventions
Onartuzumab will be administered as intravenous (IV) infusion at a dose of 10 milligrams per kilogram (mg/kg) on Day 1 and Day 15 of each 28-day cycle. The dose of onartuzumab will be based on the participant's weight at screening and will remain the same throughout the study.
Bevacizumab will be administered as IV infusion at a dose of 10 mg/kg on Day 1 and Day 15 of each 28-day cycle. The dose of bevacizumab will be based on the participant's weight at screening and will remain the same throughout the study.
Paclitaxel will be administered as IV infusion at a dose of 90 milligrams per meter-squared (mg/m\^2) on Day 1, Day 8, and Day 15 of each 28-day cycle.
Placebo matching to bevacizumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.
Placebo matching to onartuzumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
- Hoffmann-La Rochecollaborator
Study Sites (53)
Comprehensive Blood/Cancer Ctr
Bakersfield, California, 93309, United States
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, 92835, United States
Can Care Assoc Med Group Inc; Beach Cities Offices
Los Angeles, California, 90095-1772, United States
Univ of California Los Angeles
Los Angeles, California, 90095, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825, United States
Sharp Healthcare; Oncology Research Program
San Diego, California, 92123, United States
Kaiser Permanente - Vallejo
Vallejo, California, 94589, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists; SCRI
Fort Myers, Florida, 33916, United States
Suburban Hematology Oncology
Lawrenceville, Georgia, 30045, United States
Cancer Center of Kansas
Wichita, Kansas, 67214-3728, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute..
Detroit, Michigan, 48201, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
North Shore Hem Onc Associates
East Setauket, New York, 11733, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29414, United States
South Carolina Onc. Associate
Columbia, South Carolina, 29210, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404, United States
The Sarah Cannon Research Inst
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
Institut Jules Bordet
Brussels, 1000, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, 9000, Belgium
CH Jolimont - Lobbes (Jolimont)
Haine-Saint-Paul, 7100, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Institut Bergonie; Oncologie
Bordeaux, 33076, France
Centre Francois Baclesse; Gastro-Enterologie
Caen, 14076, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079, France
Centre Leon Berard
Lyon, 69008, France
Institut régional du Cancer Montpellier
Montpellier, 34298, France
Institut Curie; Oncologie Medicale
Paris, 75231, France
Centre Rene Huguenin; CONSULT SPECIALISEES
Saint-Cloud, 92210, France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, 44805, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059, France
Praxis Dr. med. Klausmann; SHOD
Aschaffenburg, 63739, Germany
Klinik Johann Wolfgang von Goethe Uni
Frankfurt am Main, 60590, Germany
Klinikum rechts der Isar der TU München; Frauenklinik
München, 81675, Germany
Universitätsklinik Tübingen; Frauenklinik
Tübingen, 72076, Germany
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Barcelona, 08035, Spain
Instituto Catalán de Oncología; Servicio de Farmacia
Barcelona, Barcelona, 08907, Spain
Hospital Universitario Puerta del Mar; Servicio de Oncologia
Cadiz, Cadiz, 11009, Spain
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
A Coruña, La Coruña, 15009, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Brighton and Sussex Univ Hosp
Brighton, BN2 5BD, United Kingdom
Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
The Clatterbridge Cancer Ctr For Oncolgy
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Mount Vernon Hospital; Centre For Cancer Treatment
Northwood, HA6 2RN, United Kingdom
Nottingham City Hospital; Oncology
Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
Dieras V, Campone M, Yardley DA, Romieu G, Valero V, Isakoff SJ, Koeppen H, Wilson TR, Xiao Y, Shames DS, Mocci S, Chen M, Schmid P. Randomized, phase II, placebo-controlled trial of onartuzumab and/or bevacizumab in combination with weekly paclitaxel in patients with metastatic triple-negative breast cancer. Ann Oncol. 2015 Sep;26(9):1904-1910. doi: 10.1093/annonc/mdv263. Epub 2015 Jul 22.
PMID: 26202594DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2010
First Posted
August 23, 2010
Study Start
March 1, 2011
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
January 20, 2017
Record last verified: 2017-01