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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 has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01186991
First received: August 9, 2010
Last updated: September 20, 2016
Last verified: September 2016

August 9, 2010
September 20, 2016
March 2011
March 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01186991 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Objective response [ Time Frame: Complete or partial response maintained ≥ 4 weeks. ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating the Safety and Efficacy of Onartuzumab (Metmab) And/Or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple Negative Breast Cancer
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
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: MetMAb
    Intravenous repeating dose
  • Drug: bevacizumab
    Intravenous repeating dose
  • Drug: paclitaxel
    Intravenous repeating dose
  • Drug: placebo
    Intravenous repeating dose
  • Experimental: Onartuzumab + Bevacizumab + Paclitaxel
    Interventions:
    • Drug: MetMAb
    • Drug: bevacizumab
    • Drug: paclitaxel
  • Experimental: Onartuzumab + Placebo + Paclitaxel
    Interventions:
    • Drug: MetMAb
    • Drug: paclitaxel
    • Drug: placebo
  • Active Comparator: Placebo + Bevacizumab + Paclitaxel
    Interventions:
    • Drug: bevacizumab
    • Drug: paclitaxel
    • Drug: placebo
Diéras 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):1904-10. doi: 10.1093/annonc/mdv263. Epub 2015 Jul 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   France,   Germany,   Spain,   United Kingdom
 
NCT01186991
OAM4861g, GO01334
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Hoffmann-La Roche
Study Director: See-Chun Phan, M.D. Genentech, Inc.
Genentech, Inc.
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP