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Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients

NCT00511459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2015-10-29

No results posted yet for this study

Summary

This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Conditions

  • Locally Recurrent and Metastatic Breast Cancer

Interventions

DRUG

AMG 386 Placebo

AMG 386 Placebo \[blinded\]

DRUG

AMG 386

AMG 386 3mg/kg IV QW \[blinded\]

DRUG

Bevacizumab

Bevacizumab 10mg/kg IV Q2W

DRUG

AMG 386

AMG 386 10mg/kg IV QW \[Open-Label\]

DRUG

AMG 386

AMG 386 10mg/kg IV QW \[blinded\]

DRUG

Paclitaxel

Paclitaxel 90mg/m2 IV QW (3 on/1 0ff)

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
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-08-31
Completion
2014-05-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Hungary
  • India
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00511459 on ClinicalTrials.gov