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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467012
First Posted: April 27, 2007
Last Update Posted: April 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chugai Pharmaceutical
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
  • Progression-free survival (PFS) [ Time Frame: event driven ]

Secondary Outcome Measures:
  • Overall Survival(OS) [ Time Frame: event driven ]
  • Time to Treatment Failure(TTF) [ Time Frame: evnt driven ]
  • Response Rate(RR) [ Time Frame: event driven ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00467012     History of Changes
Other Study ID Numbers: JO19901
First Submitted: April 26, 2007
First Posted: April 27, 2007
Last Update Posted: April 26, 2012
Last Verified: April 2012

Keywords provided by Chugai Pharmaceutical:
Inoperable metastatic breast cancer

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