Detecting circulating tumor cells in patients with luminal A breast cancer
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
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Shengjing Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Shenyang, Liaoning and 1 other locations) |
| Trial ID | NCT04065321 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include postmenopausal women with early-stage luminal A breast cancer who meet specific hormonal receptor criteria.
Not a fit: Patients with bilateral breast cancer, inflammatory breast cancer, or those who are pregnant or lactating may not benefit from this study.
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 performed: Other studies have shown promise in using circulating tumor cells as biomarkers, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Shenyang, Liaoning and 1 other locations
- 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
- Principal investigator: Jianyi Li, MD — Shengjing Hospital
- Study coordinator: Jianyi Li
- Email: sjbreast@yeah.net
- Phone: +8618940257177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.