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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326295
• Other study ID #: KYJJ-2021-186
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: March 1, 2029

Study information

• Verified date: March 2022
• Source: Hunan Cancer Hospital
• Contact: Quchang Ouyang
• Phone: +8673189762161
• Email: oyqc1969[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 1, 2029
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

• The age is more than 18 years old;

• Pathology confirmed malignant breast tumor;

• No clinical diagnosis of other malignancies, unstable complications or uncontrolled infection;

• Life expectancy is greater than 6 month;

• The main organ function is normal;

• The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance.

Exclusion Criteria

• Patients who had suffered from other malignant tumors;

• With uncontrolled bacterial, viral or fungal infections;

• With physical or mental disorders

• Without or limited civil capacity;

• Infected with human immunodeficiency virus (HIV);

• Circumstances in which the investigator considers it inappropriate to participate in this study.

Related Conditions & MeSH terms

• Breast Neoplasms
• Chemotherapy Effect
• Neoplastic Cells, Circulating

Intervention

Diagnostic Test:
• CTC detection
CTCs separation and enrichment technology. Combined with the prognosis of patients with recurrence and survival time, we explored the evaluation of CTC number, cell phenotype distribution, PDL1 and FOXC2 expression on the prognosis of early stage breast cancer patients. The research results are expected to provide a new effective index and theoretical basis for evaluating the treatment efficacy of breast cancer patients.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iDFS	The survival time from the date of tumor resection to the date of the relapse of the invasive disease.	From date of enrollment through study completion, up to 10 years.
Secondary	overall survival	The survival time from the date of recruitment to the date of death.	From date of enrollment through study completion, up to 10 years.
Secondary	Pathological complete response rate	pCR is defined as no infiltrating tumor cells in pathological examination in the primary breast and axillary lymph nodes.	From date of enrollment up to 24 weeks