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NCT00467012 Clinical Trial

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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00467012
Other study ID # JO19901
Secondary ID
Status Completed
Phase Phase 2
First received April 26, 2007
Last updated April 25, 2012
Start date April 2007
Est. completion date September 2011

Study information
Verified date April 2012
Source Chugai Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date September 2011
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility - At least 20 years old and obtained a written informed consent

- Advanced breast cancer (Stage?) or Inoperable metastatic breast cancer

- HER2 negative

- At least one measurable lesion based on RECIST criteria

- No previous chemotherapy for metastatic breast cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• bevacizumab
10mg/kg,Day1, 15 of 1 cycle(4 weeks)
• Paclitaxel
90mg/ m2,Day1, 8, 15 of 1 cycle(4 weeks)

Locations
Country Name City State
Japan Kanto Region Kanto
Japan Kinki Region Kinki
Japan Kyushu region Kyushu
Japan Sikoku region Sikoku
Japan Tohoku region Tohoku

Sponsors (1)
Lead Sponsor Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety throughout study Yes
Primary Progression-free survival (PFS) event driven No
Secondary Overall Survival(OS) event driven No
Secondary Time to Treatment Failure(TTF) evnt driven No
Secondary Response Rate(RR) event driven No
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