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Clinical Trials/NCT05621564
NCT05621564
Recruiting
Not Applicable

The Effect of Pre-operative Therapy on Response and Survival in Breast Cancer

RenJi Hospital1 site in 1 country488 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
pre-operative therapy
Conditions
Breast Cancer
Sponsor
RenJi Hospital
Enrollment
488
Locations
1
Primary Endpoint
Pathologic Complete Response
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
November 1, 2030
Last Updated
2 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wenjin Yin

Deputy Chief of Breast Surgery Department

RenJi Hospital

Eligibility Criteria

Inclusion Criteria

  • Female, Aged ≥18 years
  • Histologically confirmed primary breast cancer
  • Plan to receive pre-operative therapy
  • Adequate organ function

Exclusion Criteria

  • History of neurological or psychological disease, including epilepsy or dementia
  • Not suitable to participate in this study judged by investigators

Arms & Interventions

early breast cancer

no requirements for therapy

Intervention: pre-operative therapy

advanced breast cancer

no requirements for therapy

Intervention: pre-operative therapy

Outcomes

Primary Outcomes

Pathologic Complete Response

Time Frame: at surgery

ypT0 ypN0, ypT0/is ypN0

Secondary Outcomes

  • Disease-free Survival(From surgery until time of event up to 8 years)
  • Objective response rate(from the start of pre-operative treatment until the completion of surgery up to 6 months)

Study Sites (1)

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