Pre-operative Therapy in Breast Cancer
August 2, 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
Study Type
Observational
Enrollment (Estimated)
6032
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
- Name: Wenjin Yin
- Phone Number: 86(21)68385569
- Email: yinwenjin@renji.com
Study Locations
-
-
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Shanghai, China, 200127
- Recruiting
- Renji Hospital, School of Medicine, Shanghai Jiaotong University
-
Contact:
- Wenjin Yin
- Phone Number: 86(21)68385569
- Email: yinwenjin@renji.com
-
-
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
|
pre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy
|
|
advanced breast cancer
no requirements for 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
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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
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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.
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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
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.
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)
August 4, 2026
Last Update Submitted That Met QC Criteria
August 2, 2026
Last Verified
August 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.