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Study Evaluating the Safety and Efficacy of Onartuzumab (Metmab) And/Or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple Negative Breast Cancer

This study is currently recruiting participants.
Verified January 2013 by Genentech
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01186991
First received: August 9, 2010
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

This is a randomized, Phase II, double-blind, multicenter, placeboecontrolled trial designed to preliminarily estimate the efficacy and evaluate the safety and tolerability of MetMAb + bevacizumab + paclitaxel and MetMAb + placebo + paclitaxel versus placebo + bevacizumab + paclitaxel in patients 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).


Condition Intervention Phase
Breast Cancer
 Drug: bevacizumab
Drug: MetMAb
Drug: paclitaxel
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Phase II, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Onartuzumab (Metmab) And/Or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple Negative Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival (PFS) or death on study from any cause [ Time Frame: Time from randomization to disease progression or relapse or death from any cause within 30 days of the last study treatment, whichever occurs first. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response [ Time Frame: Complete or partial response maintained >/= 4 weeks. ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Initial complete or partial response to disease progression or death on study from any cause, whichever occurs first. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Randomization to death from any cause. ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: March 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: bevacizumab
Intravenous repeating dose
Drug: MetMAb
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Placebo Comparator: B Drug: bevacizumab
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: placebo
Intravenous repeating dose
Placebo Comparator: C Drug: MetMAb
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: placebo
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women age >/= 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically confirmed ER-, PR-, and 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 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 > 150 mmHg and/or diastolic pressure > 100 mmHg), with or without anti-hypertensive medication
  • Evidence of bleeding diathesis or coagulopathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186991

Contacts
Contact: Please reference Study ID Number: OAM4861g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Scottsdale, Arizona, United States, 85259
United States, California
Completed
Bakersfield, California, United States, 93309
Active, not recruiting
Fullerton, California, United States, 92835
Not yet recruiting
Hayward, California, United States, 94545
Terminated
Long Beach, California, United States, 90806
Completed
Los Angeles, California, United States, 90095
Not yet recruiting
Oakland, California, United States, 94611
Active, not recruiting
Redondo Beach, California, United States, 90277
Recruiting
Roseville, California, United States, 95661
Recruiting
Sacramento, California, United States, 95825
Recruiting
San Diego, California, United States, 92123
Terminated
San Francisco, California, United States, 94115
Not yet recruiting
San Francisco, California, United States, 94115
Recruiting
San Jose, California, United States, 95119
Not yet recruiting
Santa Clara, California, United States, 95051
Terminated
Santa Maria, California, United States, 93454
Not yet recruiting
South San Francisco, California, United States, 94080
Active, not recruiting
Vallejo, California, United States, 94589
Not yet recruiting
Walnut Creek, California, United States, 94596
United States, Florida
Active, not recruiting
Fort Lauderdale, Florida, United States, 33308
Completed
Fort Myers, Florida, United States, 33916
Terminated
Hollywood, Florida, United States, 33021
Recruiting
Jacksonville, Florida, United States, 32224
Terminated
Jacksonville, Florida, United States, 32207
United States, Georgia
Active, not recruiting
Lawrenceville, Georgia, United States, 30046
United States, Kansas
Active, not recruiting
Wichita, Kansas, United States, 67214
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States, 02114
Recruiting
Boston, Massachusetts, United States, 02115-6084
United States, Michigan
Active, not recruiting
Detroit, Michigan, United States, 48201
United States, Nevada
Active, not recruiting
Las Vegas, Nevada, United States, 89148
United States, New York
Recruiting
East Setauket, New York, United States, 11733
Active, not recruiting
Great Neck, New York, United States, 11021
United States, North Carolina
Completed
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Active, not recruiting
Charleston, South Carolina, United States, 29414
Active, not recruiting
Columbia, South Carolina, United States, 29210
United States, Tennessee
Active, not recruiting
Chattanooga, Tennessee, United States, 37404
Completed
Nashville, Tennessee, United States, 37203
United States, Texas
Active, not recruiting
Houston, Texas, United States, 77030
United States, Utah
Active, not recruiting
Ogden, Utah, United States, 84403
Belgium
Active, not recruiting
Brussels, Belgium, 1000
Active, not recruiting
Edegem, Belgium, 2650
Active, not recruiting
Gent, Belgium, 9000
Recruiting
Ghent, Belgium, 9000
Active, not recruiting
Hasselt, Belgium, 3500
Active, not recruiting
La Louviere, Belgium, 7100
Active, not recruiting
Liege, Belgium, 4000
Active, not recruiting
Wilrijk, Belgium, 2610
France
Active, not recruiting
Bordeaux, France, 33076
Active, not recruiting
Caen, France, 14076
Active, not recruiting
Dijon, France, 21079
Active, not recruiting
Lyon, France, 69008
Active, not recruiting
Montpellier, France, 34298
Active, not recruiting
Paris, France, 75231
Active, not recruiting
Saint Herblain, France, 44805
Active, not recruiting
St Cloud, France, 92210
Active, not recruiting
Toulouse, France, 31059
Terminated
Toulouse, France, 31052
Germany
Active, not recruiting
Aschaffenburg, Germany, 63739
Terminated
Essen, Germany, 45122
Active, not recruiting
Frankfurt Am Main, Germany, 60590
Active, not recruiting
Muenchen, Germany, 81675
Terminated
Muenchen, Germany, 80637
Terminated
Oldenburg, Germany, 26133
Active, not recruiting
Tübingen, Germany, 72076
Spain
Active, not recruiting
Barcelona, Spain, 08907
Active, not recruiting
Barcelona, Spain, 08035
Active, not recruiting
Cádiz, Spain, 11009
Terminated
Jaen, Spain, 23007
Active, not recruiting
La Curuna, Spain, 15009
Active, not recruiting
Madrid, Spain, 28222
United Kingdom
Active, not recruiting
Brighton, United Kingdom, BN2 5BD
Terminated
Chelsmford, United Kingdom, CM1 7ET
Terminated
London, United Kingdom, SE1 9RT
Active, not recruiting
Manchester, United Kingdom, M20 4BX
Active, not recruiting
Merseyside, United Kingdom, CH63 45Y
Active, not recruiting
Northwood, United Kingdom, HA6 2RN
Active, not recruiting
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Genentech
Hoffmann-La Roche
Investigators
Study Director: See-Chun Phan, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01186991     History of Changes
Other Study ID Numbers: OAM4861g, GO01334
Study First Received: August 9, 2010
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013