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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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01186991
First received: August 9, 2010
Last updated: June 6, 2013
Last verified: June 2013
History of Changes
  Purpose

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 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 ]

Enrollment: 197
Study Start Date: March 2011
Estimated Study Completion Date: November 2013
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

  Show 72 Study Locations
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: June 6, 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 June 18, 2013