Evaluation of Treatment Efficacy by Circulating Tumor Cell Phenotype Surveillance in Breast Cancer Patients

Recruiting

• Conditions: Breast Neoplasms; Neoplastic Cells, Circulating; Chemotherapy Effect
• Interventions: Diagnostic Test: CTC detection

• Registration Number: NCT05326295
• Lead Sponsor: Hunan Cancer Hospital

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.

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13
• Primary Completion: 2028-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients	CTC detection	-

Primary Outcome Measures

Name	Time	Method
iDFS	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 Outcome Measures

Name	Time	Method
Pathological complete response rate	From date of enrollment up to 24 weeks	pCR is defined as no infiltrating tumor cells in pathological examination in the primary breast and axillary lymph nodes.
overall survival	From date of enrollment through study completion, up to 10 years.	The survival time from the date of recruitment to the date of death.

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China