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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00467012
First received: April 26, 2007
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer
Drug: bevacizumab
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Safety [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Progression-free survival (PFS) [ Time Frame: event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival(OS) [ Time Frame: event driven ] [ Designated as safety issue: No ]
  • Time to Treatment Failure(TTF) [ Time Frame: evnt driven ] [ Designated as safety issue: No ]
  • Response Rate(RR) [ Time Frame: event driven ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: April 2007
Study Completion Date: September 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467012

Locations
Japan
Kanto Region
Kanto, Japan
Kinki Region
Kinki, Japan
Kyushu region
Kyushu, Japan
Sikoku region
Sikoku, Japan
Tohoku region
Tohoku, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Chair: Shingo Koganezawa Clinical research department 3
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00467012     History of Changes
Other Study ID Numbers: JO19901
Study First Received: April 26, 2007
Last Updated: April 25, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Chugai Pharmaceutical:
Inoperable metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014