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Clinical Trials/NCT03260192
NCT03260192
Recruiting
Not Applicable

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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 site in 1 country150 target enrollmentSeptember 1, 2013
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment
150
Locations
1
Primary Endpoint
death of breast cancer
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2013
End Date
December 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Liu Qiang

Professor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility Criteria

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

Outcomes

Primary Outcomes

death of breast cancer

Time Frame: 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.

The event is defined as death of breast cancer, which is a separate measure

Secondary Outcomes

  • tumor 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.)

Study Sites (1)

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