NCT05621564
Recruiting
Not Applicable
The Effect of Pre-operative Therapy on Response and Survival in Breast Cancer
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.
Investigators
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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