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

  • End date
    Mar 1, 2029
  • participants needed
  • sponsor
    Hunan Cancer Hospital
Updated on 1 May 2022
tumor cells
adjuvant chemotherapy
breast cancer staging


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.


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.

Condition Breast Neoplasms, Neoplastic Cells, Circulating, Chemotherapy Effect
Treatment CTC detection
Clinical Study IdentifierNCT05326295
SponsorHunan Cancer Hospital
Last Modified on1 May 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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