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

April 25, 2012 updated by: Chugai Pharmaceutical
To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kanto, Japan
        • Kanto region
      • Kinki, Japan
        • Kinki region
      • Kyushu, Japan
        • Kyushu region
      • Sikoku, Japan
        • Sikoku region
      • Tohoku, Japan
        • Tohoku region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: step 1
6 enrollment for 1 cycle(4 weeks)
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 2
114 enrollment through to meet the stopping criteria
Drug: bevacizumab
10mg/kg，Day1, 15 of 1 cycle(4 weeks)
Drug: Paclitaxel
90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: throughout study
throughout study
Progression-free survival (PFS)
Time Frame: event driven
event driven

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival(OS)
Time Frame: event driven
event driven
Time to Treatment Failure(TTF)
Time Frame: evnt driven
evnt driven
Response Rate(RR)
Time Frame: event driven
event driven

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharmaceutical

Investigators

  • Study Chair: Shingo Koganezawa, Clinical research department 3

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 26, 2007

First Submitted That Met QC Criteria

April 26, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

April 26, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JO19901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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