Pre-operative Therapy in Breast Cancer

February 1, 2026 updated by: Wenjin Yin, RenJi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

488

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will be selected from the hospital where they are treated

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
early breast cancer
no requirements for therapy
Drug: pre-operative therapy
pre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy
advanced breast cancer
no requirements for therapy
Drug: pre-operative therapy
pre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response
Time Frame: at surgery
ypT0 ypN0, ypT0/is ypN0
at surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: from the start of pre-operative treatment until the completion of surgery up to 6 months
the rate of complete response and partial response
from the start of pre-operative treatment until the completion of surgery up to 6 months
Disease-free Survival
Time Frame: From surgery until time of event up to 8 years
Disease-free survival time is defined as the time from date of randomization until the first occurrence of disease recurrence, distant metastasis and death from any cause.
From surgery until time of event up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 1, 2022

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2022-028-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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