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Terminated/Withdrawn
Sponsor ID
20050225

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

Sponsor ID
20050225
Clinicaltrials.gov ID
NCT00356681
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
AMG 706
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
282
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Last patient enrolled + 16 weeks of treatment

Secondary Outcome Measures

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.

Timeframe: >24 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Breast Cancer
    • Sex
    Assigned Female at Birth
    Trial Dates
    Dec 2006 - Feb 2009
    Inclusion and Exclusion Criteria
    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.