Clinical trial · Observational
Circulating Tumor Cell Detection 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The incidence of breast cancer in Chinese women has increased year by year, and luminal A breast cancer commonly occurs in early-stage and postmenopausal women. This type of breast cancer is not sensitive to chemotherapy, although it has a low mortality rate and distant metastasis rate. Studies have shown that luminal A breast cancer is sensitive to endocrine therapy. Patients with breast cancer who undergo excision should be followed up and their prognosis should be monitored regularly. At present, imaging detection is mainly used in the conventional follow-up of breast cancer, but the cost of many imaging examinations is high, so a cost-effective examination is urgently needed. Recent studies have found that circulating tumor cells can be used as a new type of tumor molecular marker, which can be used to diagnose tumors, judge the prognosis and monitor the efficacy by detecting the number and characteristic protein expression of circulating tumor cells. Because circulating tumor cells may develop abnormalities 4-6 months earlier than conventional imaging examination, as long as circulating tumor cells of patients are abnormal, timely PET-CT examination will neither miss diagnosis nor delay the condition. Simultaneously, the cost of hospitalization can be obviously reduced. This non-inferiority randomized controlled clinical trial is designed to compare the differences in postoperative conditions between circulating tumor cell detection and conventional imaging examination in patients with luminal A breast cancer without lymph node metastasis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral blood detection | Procedure | — | UNRESOLVED |
| PET-CT examination | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control group
- description
- 250 patients will be assigned into control group.
- interventionNames
- Procedure: PET-CT examination
- label
- Trial group
- description
- 250 patients will be assigned into trial group.
- interventionNames
- Procedure: Peripheral blood detection
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 5 years
- description
- Disease-free survival refers to the period from breast cancer excision to local recurrence, distant metastasis confirmed by clinical evidence, diagnosis of the second primary tumor or death of the patient.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available