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A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer

NCT00356681 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2015-10-15

No results posted yet for this study

Summary

To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.

Conditions

  • Breast Neoplasms
  • Breast Tumors
  • Breast Cancer
  • Locally Recurrent and Metastatic Breast Cancer

Interventions

DRUG

AMG 706 placebo

Blinded placebo

DRUG

Bevacizumab

Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.

DRUG

AMG 706

AMG 706 is a small organic molecule that has been shown in preclinical pharmacology and PK studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors.

DRUG

Paclitaxel

Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-02-28
Completion
2012-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00356681 on ClinicalTrials.gov