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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A Placebo

Blinded AMG 706 placebo plus paclitaxel

Group Type PLACEBO_COMPARATOR

AMG 706 placebo

Intervention Type DRUG

Blinded placebo

Paclitaxel

Intervention Type DRUG

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

Arm B Experimental

Blinded AMG 706 plus paclitaxel

Group Type EXPERIMENTAL

AMG 706

Intervention Type DRUG

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.

Paclitaxel

Intervention Type DRUG

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

Arm C Comparator

Open-label bevacizumab plus paclitaxel

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

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

Paclitaxel

Intervention Type DRUG

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

Interventions

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AMG 706 placebo

Blinded placebo

Intervention Type DRUG

Bevacizumab

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

Intervention Type 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.

Intervention Type DRUG

Paclitaxel

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

Intervention Type DRUG

Other Intervention Names

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Avastin motesanib diphosphate

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
* Measurable disease by RECIST guidelines.
* Tumor (primary or metastatic) must be HER2 negative.
* Adequate organ and hematologic function. Exclusion:
* Taxane treatment within 12 months prior to registration.
* Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
* Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
* Current or prior history of central nervous system metastases.
* Peripheral neuropathy ≥ grade 2 (CTCAE v3.0) at registration.
* History of arterial or venous thrombosis within 1 year prior to registration.
* History of bleeding diathesis or bleeding within 14 days of registration.
* Uncontrolled hypertension (systolic \>145 mmHg; diastolic \>85 mmHg).
* Clinically significant cardiac disease within 12 months of registration.
* Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.
* Prior treatment with VEGFr targeted therapies.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No