Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00467012
First received: April 26, 2007
Last updated: April 25, 2012
Last verified: April 2012

April 26, 2007
April 25, 2012
April 2007
June 2009   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Progression-free survival (PFS) [ Time Frame: event driven ] [ Designated as safety issue: No ]
  • Safety
  • Progression-free survival (PFS)
Complete list of historical versions of study NCT00467012 on ClinicalTrials.gov Archive Site
  • Overall Survival(OS) [ Time Frame: event driven ] [ Designated as safety issue: No ]
  • Time to Treatment Failure(TTF) [ Time Frame: evnt driven ] [ Designated as safety issue: No ]
  • Response Rate(RR) [ Time Frame: event driven ] [ Designated as safety issue: No ]
  • Overall Survival(OS)
  • Time to Treatment Failure(TTF)
  • Response Rate(RR)
Not Provided
Not Provided
 
Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer
Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: bevacizumab
    10mg/kg,Day1, 15 of 1 cycle(4 weeks)
  • Drug: Paclitaxel
    90mg/ m2,Day1, 8, 15 of 1 cycle(4 weeks)
  • Experimental: step 1
    6 enrollment for 1 cycle(4 weeks)
    Interventions:
    • Drug: bevacizumab
    • Drug: Paclitaxel
  • Experimental: step 2
    114 enrollment through to meet the stopping criteria
    Interventions:
    • Drug: bevacizumab
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
September 2011
June 2009   (final data collection date for primary outcome measure)
  • At least 20 years old and obtained a written informed consent
  • Advanced breast cancer (StageⅣ) or Inoperable metastatic breast cancer
  • HER2 negative
  • At least one measurable lesion based on RECIST criteria
  • No previous chemotherapy for metastatic breast cancer
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00467012
JO19901
No
Chugai Pharmaceutical
Chugai Pharmaceutical
Not Provided
Study Chair: Shingo Koganezawa Clinical research department 3
Chugai Pharmaceutical
April 2012

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