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NCT Number: NCT05326295

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Chemotherapy Effect Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

Location status: Recruiting

Location contact

Quchang Ouyang, PhD

CONTACT

[email protected]

+86 13973135318

Quchang Ouyang, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CTC detection

Diagnostic Test

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.

Primary outcomes

  1. 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

  1. overall survival

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

    The survival time from the date of recruitment to the date of death.

  2. Pathological complete response rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Quchang Ouyang

CONTACT

[email protected]

+8673189762161

Sponsors and collaborators

Lead sponsor

Hunan Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2029
First posted
Apr 13, 2022
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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