Back to resultsStudy Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Onartuzumab
Bevacizumab
Paclitaxel
Bevacizumab Placebo
Onartuzumab Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Comprehensive Blood/Cancer Ctr
- St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
- Can Care Assoc Med Group Inc; Beach Cities Offices
- Univ of California Los Angeles
- Kaiser Permanente Sacramento Medical Center
- Sharp Healthcare; Oncology Research Program
- Kaiser Permanente - Vallejo
- Holy Cross Hospital
- Florida Cancer Specialists; SCRI
- Suburban Hematology Oncology
- Cancer Center of Kansas
- Massachusetts General Hospital
- Karmanos Cancer Institute..
- Comprehensive Cancer Centers of Nevada
- North Shore Hem Onc Associates
- Duke University Medical Center
- Magee Womens Hospital
- Charleston Hematology Oncology
- South Carolina Onc. Associate
- SCRI Tennessee Oncology Chattanooga
- The Sarah Cannon Research Inst
- MD Anderson Cancer Center
- Northern Utah Associates
- Institut Jules Bordet
- UZ Antwerpen
- AZ Sint Lucas (Sint Lucas)
- CH Jolimont - Lobbes (Jolimont)
- Jessa Zkh (Campus Virga Jesse)
- CHU Sart-Tilman
- Sint Augustinus Wilrijk
- Institut Bergonie; Oncologie
- Centre Francois Baclesse; Gastro-Enterologie
- Centre Georges Francois Leclerc; Oncologie 3
- Centre Leon Berard
- Institut régional du Cancer Montpellier
- Institut Curie; Oncologie Medicale
- Ico Rene Gauducheau; Oncologie
- Centre Rene Huguenin; CONSULT SPECIALISEES
- Institut Claudius Regaud; Departement Oncologie Medicale
- Praxis Dr. med. Klausmann; SHOD
- Klinik Johann Wolfgang von Goethe Uni
- Klinikum rechts der Isar der TU München; Frauenklinik
- Universitätsklinik Tübingen; Frauenklinik
- Hospital Universitario Puerta del Mar; Servicio de Oncologia
- Hospital Universitario Puerta de Hierro
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
- Instituto Catalán de Oncología; Servicio de Farmacia
- Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
- Brighton and Sussex Univ Hosp
- Christie Hospital NHS Trust
- Mount Vernon Hospital; Centre For Cancer Treatment
- Nottingham City Hospital; Oncology
- The Clatterbridge Cancer Ctr For Oncolgy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Onartuzumab + Bevacizumab + Paclitaxel
Onartuzumab + Placebo + Paclitaxel
Placebo + Bevacizumab + Paclitaxel
Arm Description
Participants 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).
Participants 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).
Participants 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).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
PFS According to RECIST v1.1 in Participants Who Have not Received Prior Systemic Therapy
Percentage of Participants With Objective Response as Assessed by the Investigator According to RECIST v1.1
Duration of Response as Assessed by the Investigator Using RECIST v1.1
Overall Survival (OS)
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)
Number of Cycles of Treatment Received for Onartuzumab, Paclitaxel, and Bevacizumab During the Study
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Onartuzumab
Serum Levels of ATAs Against Onartuzumab
Full Information
NCT ID
NCT01186991
First Posted
August 9, 2010
Last Updated
January 19, 2017
Sponsor
Genentech, Inc.
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT01186991
Brief Title
Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
Hoffmann-La Roche
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Onartuzumab + Bevacizumab + Paclitaxel
Arm Type
Experimental
Arm Description
Participants 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).
Arm Title
Onartuzumab + Placebo + Paclitaxel
Arm Type
Experimental
Arm Description
Participants 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).
Arm Title
Placebo + Bevacizumab + Paclitaxel
Arm Type
Active Comparator
Arm Description
Participants 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).
Intervention Type
Drug
Intervention Name(s)
Onartuzumab
Other Intervention Name(s)
MetMAb
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab Placebo
Intervention Description
Placebo matching to bevacizumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Onartuzumab Placebo
Intervention Description
Placebo matching to onartuzumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.
Primary Outcome Measure Information:
Title
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
Time Frame
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 Outcome Measure Information:
Title
PFS According to RECIST v1.1 in Participants Who Have not Received Prior Systemic Therapy
Time Frame
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)
Title
Percentage of Participants With Objective Response as Assessed by the Investigator According to RECIST v1.1
Time Frame
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)
Title
Duration of Response as Assessed by the Investigator Using RECIST v1.1
Time Frame
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)
Title
Overall Survival (OS)
Time Frame
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)
Title
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)
Time Frame
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)
Title
Number of Cycles of Treatment Received for Onartuzumab, Paclitaxel, and Bevacizumab During the Study
Time Frame
Day 1 Cycle 1 (cycle length=28 days) up to last dose of study drug or study discontinuation/termination, whichever is later (overall up to 5 years)
Title
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Onartuzumab
Time Frame
Predose on Day 1 of Cycles 1-4 (cycle length=28 days), 30 days after last administration of onartuzumab or initiation of another therapy (overall up to 5 years)
Title
Serum Levels of ATAs Against Onartuzumab
Time Frame
Predose on Day 1 of Cycles 1-4 (cycle length=28 days), 30 days after last administration of onartuzumab or initiation of another therapy (overall up to 5 years)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Blood/Cancer Ctr
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Can Care Assoc Med Group Inc; Beach Cities Offices
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1772
Country
United States
Facility Name
Univ of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Kaiser Permanente Sacramento Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Sharp Healthcare; Oncology Research Program
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Florida Cancer Specialists; SCRI
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Suburban Hematology Oncology
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3728
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Karmanos Cancer Institute..
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
North Shore Hem Onc Associates
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Charleston Hematology Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
South Carolina Onc. Associate
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
The Sarah Cannon Research Inst
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northern Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ Sint Lucas (Sint Lucas)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CH Jolimont - Lobbes (Jolimont)
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Jessa Zkh (Campus Virga Jesse)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Sint Augustinus Wilrijk
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Institut Bergonie; Oncologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Francois Baclesse; Gastro-Enterologie
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Georges Francois Leclerc; Oncologie 3
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Ico Rene Gauducheau; Oncologie
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Rene Huguenin; CONSULT SPECIALISEES
City
St Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut Claudius Regaud; Departement Oncologie Medicale
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Praxis Dr. med. Klausmann; SHOD
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Klinik Johann Wolfgang von Goethe Uni
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Frauenklinik
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinik Tübingen; Frauenklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Hospital Universitario Puerta del Mar; Servicio de Oncologia
City
Cádiz
State/Province
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Instituto Catalán de Oncología; Servicio de Farmacia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
City
La Coruña
ZIP/Postal Code
15009
Country
Spain
Facility Name
Brighton and Sussex Univ Hosp
City
Brighton
ZIP/Postal Code
BN2 5BD
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Mount Vernon Hospital; Centre For Cancer Treatment
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital; Oncology
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Ctr For Oncolgy
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26202594
Citation
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.
Results Reference
derived
Learn more about this trial
Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer
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