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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467012
First Posted: April 27, 2007
Last Update Posted: April 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chugai Pharmaceutical
April 26, 2007
April 27, 2007
April 26, 2012
April 2007
June 2009   (Final data collection date for primary outcome measure)
  • Safety [ Time Frame: throughout study ]
  • Progression-free survival (PFS) [ Time Frame: event driven ]
  • 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 ]
  • Time to Treatment Failure(TTF) [ Time Frame: evnt driven ]
  • Response Rate(RR) [ Time Frame: event driven ]
  • 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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: Female
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00467012
JO19901
No
Not Provided
Not Provided
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