Clinical trial Recruiting at 1 site Observational Ages 18 to 75 Women only

Evaluating tumor cell characteristics in breast cancer patients

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

Run by Hunan Cancer Hospital · NCT05326295 · Data updated 2026-11-12

This study is testing if tracking certain tumor cells in breast cancer patients can help predict how well they respond to treatment after chemotherapy and surgery.

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexWomen only
Enrollment1000 (estimated)
SponsorHunan Cancer Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Changsha, Hunan)
StatusRecruiting
StartedMarch 1, 2019
Main results expectedMarch 1, 2028
Study endsMarch 1, 2029
Registry record updatedApril 13, 2022
Trial IDNCT05326295 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 with a confirmed diagnosis of malignant breast tumors who have completed neoadjuvant chemotherapy and surgery.

Probably not a fit

Patients with other malignancies, uncontrolled infections, or significant physical or mental disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the efficacy of circulating tumor cell (CTC) surveillance in predicting treatment response in breast cancer patients who have undergone neoadjuvant chemotherapy and surgery. It will evaluate how CTC phenotype correlates with invasive-disease free survival, overall survival, and metastasis. Additionally, the study will analyze the expression of specific markers, PDL1 and FOXC3, on CTCs to further understand their prognostic significance.

Why it matters

Potential benefit: If successful, this study could provide a reliable method for predicting patient outcomes and tailoring treatment strategies in breast cancer.

How similar studies have gone: Other studies have shown promise in using CTC surveillance for prognosis in various cancers, suggesting potential success for this approach in breast cancer.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Hunan Cancer Hospital
    Changsha, Hunan, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.