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
Overview
- Phase
- Phase 2
- Intervention
- AMG 706 placebo
- Conditions
- Breast Neoplasms
- Sponsor
- Amgen
- Enrollment
- 282
- Primary Endpoint
- Objective response rate, measured radiologically and assessed by an independent review committee.
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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.
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A Placebo
Blinded AMG 706 placebo plus paclitaxel
Intervention: AMG 706 placebo
Arm A Placebo
Blinded AMG 706 placebo plus paclitaxel
Intervention: Paclitaxel
Arm B Experimental
Blinded AMG 706 plus paclitaxel
Intervention: AMG 706
Arm B Experimental
Blinded AMG 706 plus paclitaxel
Intervention: Paclitaxel
Arm C Comparator
Open-label bevacizumab plus paclitaxel
Intervention: Bevacizumab
Arm C Comparator
Open-label bevacizumab plus paclitaxel
Intervention: Paclitaxel
Outcomes
Primary Outcomes
Objective response rate, measured radiologically and assessed by an independent review committee.
Time Frame: Last patient enrolled + 16 weeks of treatment
Secondary Outcomes
- 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)