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Pre-operative Therapy in Breast Cancer

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05621564
Enrollment
6032
Registered
2022-11-18
Start date
2022-11-01
Completion date
2030-11-01
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGpre-operative therapy

pre-operative therapy includes pre-operative chemotherapy, radiation, endocrine therapy, target therapy and other anti-tumor therapy

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pathologic Complete Responseat surgeryypT0 ypN0, ypT0/is ypN0

Secondary

MeasureTime frameDescription
Objective response ratefrom the start of pre-operative treatment until the completion of surgery up to 6 monthsthe rate of complete response and partial response
Disease-free SurvivalFrom surgery until time of event up to 8 yearsDisease-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.

Countries

China

Contacts

CONTACTWenjin Yin
yinwenjin@renji.com86(21)68385569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026