- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467012
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
-
-
-
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)
|
10mg/kg,Day1, 15 of 1 cycle(4 weeks)
90mg/ m2,Day1, 8, 15 of 1 cycle(4 weeks)
|
Experimental: step 2
114 enrollment through to meet the stopping criteria
|
10mg/kg,Day1, 15 of 1 cycle(4 weeks)
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
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
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Paclitaxel
- Bevacizumab
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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