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


Phase 2
20 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

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

Inclusion Criteria


- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety

Outcome Time Frame:

throughout study

Safety Issue:

Yes

Principal Investigator

Shingo Koganezawa

Investigator Role:

Study Chair

Investigator Affiliation:

Clinical research department 3

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JO19901

NCT ID:

NCT00467012

Start Date:

April 2007

Completion Date:

September 2011

Related Keywords:

  • Metastatic Breast Cancer
  • Inoperable metastatic breast cancer
  • Breast Neoplasms

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