Pre-operative Therapy in Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621564
• Other study ID #: LY2022-028-B
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: November 2030

Study information

• Verified date: April 2024
• Source: RenJi Hospital
• Contact: Wenjin Yin
• Phone: 86(21)68385569
• Email: yinwenjin[@]renji.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 488
• Est. completion date: November 2030
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response	ypT0 ypN0, ypT0/is ypN0	at surgery
Secondary	Objective response rate	the rate of complete response and partial response	from the start of pre-operative treatment until the completion of surgery up to 6 months
Secondary	Disease-free Survival	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