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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Xijing Hospital
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01652560
First received: July 21, 2012
Last updated: July 25, 2012
Last verified: July 2012
  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 Xijing Hospital:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: From enrollment to disease progression ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: July 21, 2012
Last Updated: July 25, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014