Pre-operative Therapy in Breast Cancer
The Effect of Pre-operative Therapy on Response and Survival in Breast Cancer
1 other identifier
observational
488
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
Longer than P75 for all trials
1 active site
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
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 8, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2030
February 3, 2026
February 1, 2026
8 years
November 8, 2022
February 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pathologic Complete Response
ypT0 ypN0, ypT0/is ypN0
at surgery
Secondary Outcomes (2)
Objective response rate
from the start of pre-operative treatment until the completion of surgery up to 6 months
Disease-free Survival
From surgery until time of event up to 8 years
Study Arms (2)
early breast cancer
no requirements for therapy
advanced breast cancer
no requirements for therapy
Interventions
pre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy
Eligibility Criteria
The study population will be selected from the hospital where they are treated
You may qualify if:
- Female, Aged ≥18 years
- Histologically confirmed primary breast cancer
- Plan to receive pre-operative therapy
- Adequate organ function
You may not qualify if:
- History of neurological or psychological disease, including epilepsy or dementia
- Not suitable to participate in this study judged by investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127, China
Related Publications (1)
Chen X, Zhao Y, Wang Y, Ye Y, Xu S, Zhou L, Lin Y, Lu J, Yin W. Serum lipid ratios as novel prognostic biomarkers for patients with locally advanced breast cancer treated with neoadjuvant therapy. Postgrad Med. 2024 Jun;136(5):541-550. doi: 10.1080/00325481.2024.2370235. Epub 2024 Jun 24.
PMID: 38912905DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Chief of Breast Surgery Department
Study Record Dates
First Submitted
November 8, 2022
First Posted
November 18, 2022
Study Start
November 1, 2022
Primary Completion (Estimated)
November 1, 2030
Study Completion (Estimated)
November 1, 2030
Last Updated
February 3, 2026
Record last verified: 2026-02