Status:

COMPLETED

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

Lead Sponsor:

Chugai Pharmaceutical

Conditions:

Metastatic Breast Cancer

Eligibility:

FEMALE

20+ years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2011

    Estimated Enrollment :

    122 Patients enrolled

    Trial Details

    Trial ID

    NCT00467012

    Start Date

    April 1 2007

    End Date

    September 1 2011

    Last Update

    April 26 2012

    Active Locations (5)

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    Page 1 of 2 (5 locations)

    1

    Kanto Region

    Kanto, Japan

    2

    Kinki Region

    Kinki, Japan

    3

    Kyushu region

    Kyushu, Japan

    4

    Sikoku region

    Sikoku, Japan