Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03260192
• Other study ID #: LQBC020
• Status: Recruiting
• Start date: September 1, 2013
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Shunying Li
• Phone: +86-15915939702
• Email: lishunying[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to evaluate patients' response to neoadjuvant chemotherapy

Description:

Neoadjuvant chemotherapy(NAC) is traditionally for locally advanced disease, converting an inoperable to a resectable tumor.In recent years, it has become an option for patients of lower tumor stage to increase the possibility of breast conserving therapy. An effective method to monitor the response to NAC is important.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Female patients undergoing NAC

• Age: 18-70 yrs

• Any menopausal status

• Any hormal receptor status

Exclusion Criteria:

• Metastasis discovered during NAC

• Lost more than 2 blood samples during NAC and surgery

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Sunyat-sen Memorial Hospital	Guandong	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death of breast cancer	The event is defined as death of breast cancer, which is a separate measure	Follow-up time is estimated to be up to 5 years. The duration is from the date of diagnosis to date of death of breast cancer or date of death of any cause, whichever come first.
Secondary	tumor recurrence or distant metastasis	The event is defined as breast cancer local recurrence or distant metastasis	Follow-up time is estimated to be up to 5 years.The duration is from diagnosis to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year.