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

Tracking Information

First Received Date ^ICMJE

July 24, 2006

Last Updated Date

February 25, 2010

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective response rate, measured radiologically and assessed by an independent review committee. [ Time Frame: Last patient enrolled + 16 weeks of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Objective response rate, measured radiologically and assessed by an independent review committee.

Change History

Complete list of historical versions of study NCT00356681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: >24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination With Paclitaxel, or Open-Label Bevacizumab in Combination With Paclitaxel, as First Line Therapy in Women With HER2 Negative Locally Recurrent or Metastatic Breast Cancer

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: AMG 706 placebo
AMG 706 placebo 125mg QD until disease progression, consent withdrawal or unacceptable toxicity
Drug: Bevacizumab
Bevacizumab 10 mg/kg IV every 14 days until disease progression, consent withdrawal or unacceptable toxicity

Other Name: Avastin
Drug: AMG 706
AMG 706 125mg PO QD until disease progression, consent withdrawal or unacceptable toxicity

Study Arms / Comparison Groups

A: Placebo Comparator
Blinded AMG 706 placebo

Intervention: Drug: AMG 706 placebo
B: Active Comparator
Blinded AMG 706

Intervention: Drug: AMG 706
C: Experimental
Open-label bevacizumab

Intervention: Drug: Bevacizumab

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

282

Estimated Completion Date

December 2013

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, France, Germany, Hong Kong, Hungary, India, Ireland, New Zealand, Poland, Spain

Administrative Information

NCT ID ^ICMJE

NCT00356681

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20050225, CIRG/TORI 010

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

February 2010

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