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Clinical Trials/NCT05326295
NCT05326295
Recruiting
Not Applicable

Surveillance of Circulating Tumor Cell Phenotype in Early Stage Breast Cancer Patients With Neoadjuvant Chemotherapy or Adjuvant Chemotherapy

Hunan Cancer Hospital1 site in 1 country1,000 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
Hunan Cancer Hospital
Enrollment
1000
Locations
1
Primary Endpoint
iDFS
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

The phenotype of circulating tumor cells (CTCs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with/without adjuvant chemotherapy. The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the prognosis of breast cancer patients.

Detailed Description

The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the treatment response of neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. This study also aims to evaluate the efficacy of CTCs surveillance in predicting invasive-disease free survival (iDFS), overall survival (OS) and metastasis. Additionally, this study evaluate the expression of PDL1 and FOXC3 on CTCs.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
March 1, 2029
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

iDFS

Time Frame: From date of enrollment through study completion, up to 10 years.

The survival time from the date of tumor resection to the date of the relapse of the invasive disease.

Secondary Outcomes

  • Pathological complete response rate(From date of enrollment up to 24 weeks)
  • overall survival(From date of enrollment through study completion, up to 10 years.)

Study Sites (1)

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