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

Conditions

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 Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital ， Fourth Military Medical University
        • Contact:
        • Contact:

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

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.

Sponsor

LiNanlin,Ph.D, Chief Physician,Clinical Professor

Collaborators

Roche Pharma AG

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

Keywords

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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