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

This study is ongoing, but not recruiting participants.

First Received: April 26, 2007 Last Updated: October 28, 2008 History of Changes

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00467012

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Bevacizumab

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	120
Study Start Date:	April 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
step 1: Experimental 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)
step 2: Experimental 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

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

Locations

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

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Chair:

Shingo Koganezawa

Clinical research department 3

More Information

No publications provided

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	JO19901
Study First Received:	April 26, 2007
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00467012 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Chugai Pharmaceutical:

Inoperable metastatic breast cancer

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Tubulin Modulators
Breast Neoplasms
Antimitotic Agents

Bevacizumab
Angiogenesis Inhibitors
Antineoplastic Agents, Phytogenic
Breast Diseases

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Breast Neoplasms
Bevacizumab
Antimitotic Agents
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009