- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01652560
Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy (BIBC)
July 25, 2012 updated by: LiNanlin,Ph.D, Chief Physician,Clinical Professor
- The purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nanlin Li, Phd
- Phone Number: +86-186-2963-7041
- Email: nanlin-74@163.com
Study Contact Backup
- Name: Hongyu Xiao, Master
- Phone Number: +86-186-2963-7040
- Email: louch2008@116.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Hospital , Fourth Military Medical University
-
Contact:
- Nanlin Li, Ph.D
- Phone Number: +86-186-2963-7041
- Email: nanlin-74@163.com
-
Contact:
- Hongyu Xiao, Master
- Phone Number: +86-186-2963-7040
- Email: louch2008@126.com
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Breast cancer patients of vascular endocrine surgery department in Xijing Hospital
Description
Inclusion Criteria:
- HER2-negative breast cancer patients
- Without surgery
- Plans to neoadjuvant chemotherapy
Exclusion Criteria:
- HER2-positive breast cancer patients
- Post-operative patients
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
bevacizumab combined neoadjuvant chemotherapy
|
The patients will be treated with Avastin combined neoadjuvant chemotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: From enrollment to disease progression
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
|
From enrollment to disease progression
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall response
Time Frame: From enrollment to disease progression
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
|
From enrollment to disease progression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
June 1, 2012
Primary Completion (Anticipated)
June 1, 2014
Study Completion (Anticipated)
September 1, 2014
Study Registration Dates
First Submitted
July 21, 2012
First Submitted That Met QC Criteria
July 25, 2012
First Posted (Estimate)
July 30, 2012
Study Record Updates
Last Update Posted (Estimate)
July 30, 2012
Last Update Submitted That Met QC Criteria
July 25, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QTDS-01
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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