Clinical trial Recruiting at 2 sites Observational Ages 18 to 60 Women only

Detecting circulating tumor cells in patients with luminal A breast cancer

Official title: Effect of Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer Without Lymph Node Metastasis Instead of Conventional Imaging Examination After Operation: a Non-Inferiority Randomized Controlled Clinical Trial

Run by Shengjing Hospital · NCT04065321 · Data updated 2026-11-12

This study is testing if checking for circulating tumor cells in the blood can help doctors better monitor and treat women with luminal A breast cancer after surgery.

More Breast Neoplasms trials

Quick facts

Study typeObservational
Ages18 Years to 60 Years
SexWomen only
Enrollment500 (estimated)
SponsorShengjing Hospital
Academic / other
Drugs / interventionschemotherapy
Locations2 sites (Shenyang, Liaoning and 1 other locations)
StatusRecruiting
StartedOctober 1, 2019
Main results expectedSeptember 30, 2024
Study endsSeptember 30, 2029
Registry record updatedMay 5, 2022
Trial IDNCT04065321 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include postmenopausal women with early-stage luminal A breast cancer who meet specific hormonal receptor criteria.

Probably not a fit

Patients with bilateral breast cancer, inflammatory breast cancer, or those who are pregnant or lactating 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 focuses on patients with luminal A breast cancer, a common type among early-stage and postmenopausal women. It aims to evaluate the effectiveness of detecting circulating tumor cells (CTCs) as a cost-effective method for monitoring prognosis and treatment efficacy, compared to traditional imaging techniques. The study will involve PET-CT examinations and peripheral blood detection to assess the number and protein expression of CTCs. By following patients post-surgery, the study seeks to provide insights into the potential of CTCs as molecular markers for breast cancer management.

Why it matters

Potential benefit: If successful, this study could provide a more affordable and effective method for monitoring breast cancer prognosis and treatment response.

How similar studies have gone: Other studies have shown promise in using circulating tumor cells as biomarkers, indicating potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* estrogen receptor (≥ 10%), progesterone receptor (≥ 10%) and epidermal growth factor receptor 2 negative;
* proliferation index Ki-67 \< 20%;
* no lymph node metastasis;
* systemic therapy (chemotherapy, radiotherapy and endocrine therapy) in accordance with the National Comprehensive Cancer Network guidelines;
* provision of informed consent of patients and their families.

Exclusion Criteria:

* Bilateral breast cancer;
* inflammatory breast cancer;
* pregnancy or lactation;
* history of other cancers or chest radiotherapy.

Where it's running

  • Shengjing Hospital of China Medical University
    Shenyang, Liaoning, China
    Recruiting
  • Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
    Shenyang, Liaoning, 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.