Back to resultsA Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer
Primary Purpose
Breast Neoplasms, Breast Tumors, Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 706 placebo
Bevacizumab
AMG 706
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring AMG 706, Paclitaxel, Metastatic Breast Cancer, Antiangiogenic, Bevacizumab
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. 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
Arm A Placebo
Arm B Experimental
Arm C Comparator
Arm Description
Blinded AMG 706 placebo plus paclitaxel
Blinded AMG 706 plus paclitaxel
Open-label bevacizumab plus paclitaxel
Outcomes
Primary Outcome Measures
Objective response rate, measured radiologically and assessed by an independent review committee.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00356681
Brief Title
A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to close study
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Breast Tumors, Breast Cancer, Locally Recurrent and Metastatic Breast Cancer
Keywords
AMG 706, Paclitaxel, Metastatic Breast Cancer, Antiangiogenic, Bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A Placebo
Arm Type
Placebo Comparator
Arm Description
Blinded AMG 706 placebo plus paclitaxel
Arm Title
Arm B Experimental
Arm Type
Experimental
Arm Description
Blinded AMG 706 plus paclitaxel
Arm Title
Arm C Comparator
Arm Type
Active Comparator
Arm Description
Open-label bevacizumab plus paclitaxel
Intervention Type
Drug
Intervention Name(s)
AMG 706 placebo
Intervention Description
Blinded placebo
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.
Intervention Type
Drug
Intervention Name(s)
AMG 706
Other Intervention Name(s)
motesanib diphosphate
Intervention Description
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
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.
Primary Outcome Measure Information:
Title
Objective response rate, measured radiologically and assessed by an independent review committee.
Time Frame
Last patient enrolled + 16 weeks of treatment
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21429799
Citation
Martin M, Roche H, Pinter T, Crown J, Kennedy MJ, Provencher L, Priou F, Eiermann W, Adrover E, Lang I, Ramos M, Latreille J, Jagiello-Gruszfeld A, Pienkowski T, Alba E, Snyder R, Almel S, Rolski J, Munoz M, Moroose R, Hurvitz S, Banos A, Adewoye H, Hei YJ, Lindsay MA, Rupin M, Cabaribere D, Lemmerick Y, Mackey JR; TRIO 010 investigators. Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol. 2011 Apr;12(4):369-76. doi: 10.1016/S1470-2045(11)70037-7. Epub 2011 Mar 21. Erratum In: Lancet Oncol. 2011 Aug;12(8):722.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer
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