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Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy (BIBC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01652560
First Posted: July 30, 2012
Last Update Posted: July 30, 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.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital
  Purpose
- 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.

Condition Intervention
Breast Cancer Bevacizumab Neoadjuvant Chemotherapy Molecular Targeted Therapy Drug: bevacizumab

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
bevacizumab combined neoadjuvant chemotherapy Drug: bevacizumab
The patients will be treated with Avastin combined neoadjuvant chemotherapy
Other Name: Avastin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer patients of vascular endocrine surgery department in Xijing Hospital
Criteria

Inclusion Criteria:

  • HER2-negative breast cancer patients
  • Without surgery
  • Plans to neoadjuvant chemotherapy

Exclusion Criteria:

  • HER2-positive breast cancer patients
  • Post-operative patients
  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): NCT01652560


Contacts
Contact: Nanlin Li, Phd +86-186-2963-7041 nanlin-74@163.com
Contact: Hongyu Xiao, Master +86-186-2963-7040 louch2008@116.com

Locations
China, Shaanxi
Xijing Hospital , Fourth Military Medical University Recruiting
Xi`an, Shaanxi, China, 710032
Contact: Nanlin Li, Ph.D    +86-186-2963-7041    nanlin-74@163.com   
Contact: Hongyu Xiao, Master    +86-186-2963-7040    louch2008@126.com   
Sponsors and Collaborators
LiNanlin,Ph.D, Chief Physician,Clinical Professor
Roche Pharma AG
  More Information

Responsible Party: LiNanlin,Ph.D, Chief Physician,Clinical Professor, The department of Vascular endocrine surgery, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01652560     History of Changes
Other Study ID Numbers: QTDS-01
First Submitted: July 21, 2012
First Posted: July 30, 2012
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital:
bevacizumab
neoadjuvant chemotherapy
HER2-negative breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents