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

Phase 2

Terminated

• Conditions: Breast Tumors; Breast Cancer; Locally Recurrent and Metastatic Breast Cancer; Breast Neoplasms
• Interventions: Drug: AMG 706 placebo; Drug: AMG 706; Drug: Bevacizumab; Drug: Paclitaxel

• Registration Number: NCT00356681
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-26
• Study Start: 2006-12
• Primary Completion: 2009-02
• Study Completion: 2012-08
• Disposition First Submitted: 2015-04-16
• Disposition First Submitted QC: 2015-04-16
• Disposition First Posted: 2015-05-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 282

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A Placebo	AMG 706 placebo	Blinded AMG 706 placebo plus paclitaxel
Arm B Experimental	Paclitaxel	Blinded AMG 706 plus paclitaxel
Arm B Experimental	AMG 706	Blinded AMG 706 plus paclitaxel
Arm A Placebo	Paclitaxel	Blinded AMG 706 placebo plus paclitaxel
Arm C Comparator	Bevacizumab	Open-label bevacizumab plus paclitaxel
Arm C Comparator	Paclitaxel	Open-label bevacizumab plus paclitaxel

Primary Outcome Measures

Name	Time	Method
Objective response rate, measured radiologically and assessed by an independent review committee.	Last patient enrolled + 16 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Progression free survival, duration of response, clinical benefit rate (percentage of subjects with complete response, partial response or stable disease lasting >24 weeks), overall survival and incidence of adverse events.	>24 weeks