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

Recruiting
Conditions
Breast Cancer
Registration Number
NCT03260192
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
150
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
death of breast cancerFollow-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 Outcome Measures
NameTimeMethod
tumor recurrence or distant metastasisFollow-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.

The event is defined as breast cancer local recurrence or distant metastasis

Trial Locations

Locations (1)

Sunyat-sen Memorial Hospital

🇨🇳

Guandong, Guangdong, China

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