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

This study has been terminated.
(Sponsor decision to close study)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00356681
First received: July 24, 2006
Last updated: September 12, 2012
Last verified: September 2012

July 24, 2006
September 12, 2012
December 2006
February 2009   (final data collection date for primary outcome measure)
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 ]
Objective response rate, measured radiologically and assessed by an independent review committee.
Complete list of historical versions of study NCT00356681 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Breast Neoplasms
  • Breast Tumors
  • Breast Cancer
  • Locally Recurrent and Metastatic Breast Cancer
  • 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
  • Placebo Comparator: Arm A Placebo
    Blinded AMG 706 placebo
    Intervention: Drug: AMG 706 placebo
  • Experimental: Arm B Experimental
    Blinded AMG 706
    Intervention: Drug: AMG 706
  • Active Comparator: Arm C Comparator
    Open-label bevacizumab
    Intervention: Drug: Bevacizumab
Martin M, Roche H, Pinter T, Crown J, Kennedy MJ, Provencher L, Priou F, Eiermann W, Adrover E, Lang I, Ramos M, Latreille J, Jagiełło-Gruszfeld A, Pienkowski T, Alba E, Snyder R, Almel S, Rolski J, Munoz M, Moroose R, Hurvitz S, Baños 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
282
August 2012
February 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00356681
20050225, CIRG/TORI 010
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
September 2012

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