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

Breast Cancer Clinical Trial

— BIBC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01652560
• Other study ID #: QTDS-01
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2012
• Last updated: July 25, 2012
• Start date: June 2012
• Est. completion date: September 2014

Study information

• Verified date: July 2012
• Source: Xijing Hospital
• Contact: Nanlin Li, Phd
• Phone: +86-186-2963-7041
• Email: nanlin-74[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

- 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• HER2-negative breast cancer patients

• Without surgery

• Plans to neoadjuvant chemotherapy

Exclusion Criteria:

• HER2-positive breast cancer patients

• Post-operative patients

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bevacizumab
• Breast Cancer
• Breast Neoplasms
• Molecular Targeted Therapy
• Neoadjuvant Chemotherapy

Intervention

Drug:
• bevacizumab
The patients will be treated with Avastin combined neoadjuvant chemotherapy

Locations

Country	Name	City	State
China	Xijing Hospital , Fourth Military Medical University	Xi`an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
LiNanlin,Ph.D, Chief Physician,Clinical Professor	Roche Pharma AG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	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	No
Secondary	overall response	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	No