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| ID | Type | Description | Link |
|---|---|---|---|
| GO01334 | Other Identifier | Hoffmann-La Roche | |
| 2010-020101-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Onartuzumab + Bevacizumab + Paclitaxel | Experimental | 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). |
|
| Onartuzumab + Placebo + Paclitaxel | Experimental | 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). |
|
| Placebo + Bevacizumab + Paclitaxel | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onartuzumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Bevacizumab Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Blood/Cancer Ctr | Bakersfield | California | 93309 | United States | ||
| St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26202594 | Derived | 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. |
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| Bevacizumab | Drug | 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. |
|
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| Paclitaxel | Drug | 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. |
|
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| Bevacizumab Placebo | Drug | Placebo matching to bevacizumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle. |
|
| Onartuzumab Placebo | Drug | Placebo matching to onartuzumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle. |
|
| 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) |
| Number of Cycles of Treatment Received for Onartuzumab, Paclitaxel, and Bevacizumab During the Study | 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) |
| Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Onartuzumab | 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) |
| Serum Levels of ATAs Against Onartuzumab | 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) |
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C584058 | onartuzumab |
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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