NCT01652560

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

July 21, 2012

Last Update Submit

July 25, 2012

Conditions

Keywords

bevacizumabneoadjuvant chemotherapyHER2-negative breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • overall response

    From enrollment to disease progression

Study Arms (1)

bevacizumab combined neoadjuvant chemotherapy

Drug: bevacizumab

Interventions

The patients will be treated with Avastin combined neoadjuvant chemotherapy

Also known as: Avastin
bevacizumab combined neoadjuvant chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer patients of vascular endocrine surgery department in Xijing Hospital

You may qualify if:

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

You may not qualify if:

  • HER2-positive breast cancer patients
  • Post-operative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital , Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Hongyu Xiao, Master

CONTACT

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The department of Vascular endocrine surgery

Study Record Dates

First Submitted

July 21, 2012

First Posted

July 30, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations