Clinical trial · Observational
CTC Changes and Efficacy of Neoadjuvant Chemotherapy for Triple-negative Breast Cancer
Circulating Tumor Cell Changes and Efficacy of Neoadjuvant Chemotherapy for Triple-negative Breast Cancer: a Cohort 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)
Chemotherapy before operation for malignant tumors can reduce the size of tumors to a certain extent, even eliminate micrometastases. Chemotherapy can also detect the sensitivity of chemotherapeutic drugs and create opportunities for breast-conserving or surgical treatment for patients. This may lead to high survival opportunities for triple-negative breast cancer patients who are not sensitive to targeted therapy or endocrine therapy. However, during neoadjuvant therapy, CT or MRI tests are needed to monitor the patient's condition. Therefore, if there is any deterioration, to consider changing the treatment regimen or immediately carrying out surgery is necessary. However, because of the need for multiple imaging examinations during neoadjuvant therapy, which will increase medical costs, to explore a cheaper examination method is necessary . Circulating tumor cells in peripheral blood are derived from the shedding of breast cancer lesions. Detection of these circulating tumor cells may monitor the therapeutic effect on breast cancer, and the cost of detecting circulating tumor cells is much lower than that of conventional PET-CT, which can obviously reduce the medical costs of patients. However, there is no clinical study on the changes of circulating tumor cells and the efficacy of neoadjuvant chemotherapy in the treatment of triple-negative breast cancer in and outside China.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Taxanes or/and anthracycline-based therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Sensitivity group
- description
- 100 patients will be assigned into sensitivity group according to the actual situation of them.
- interventionNames
- Drug: Taxanes or/and anthracycline-based therapy
- label
- Drug resistance group
- description
- 100 patients will be assigned into drug resistance according to the actual situation of them.
- interventionNames
- Drug: Taxanes or/and anthracycline-based therapy
Primary outcomes (1)
- measure
- Efficacy of neoadjuvant chemotherapy
- timeFrame
- At 18 weeks
- description
- The efficacy will be evaluated by the response evaluation criteria in solid tumors (RECIST) score, which is based on CT or X-ray results. (1) Complete response (CR): disappearance of all lesions; (2) partial response (PR): 30% decrease in sum of all target lesions in longest axis measurement; (3) stable disease (SD): the sum of the longest diameter of all lesions decreases but does not reach PR or increases but does not reach PD; (4) progressive disease (PD): 20% increase in the sum of the longest diameter or appearance of new lesions. SD: One or more non-target lesions and/or tumor markers are higher than normal and persistent.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * triple-negative breast cancer confirmed by breast biopsy; * stage III breast cancer (IIIA-C) assessed by CT or MRI; * neoadjuvant chemotherapy; * informed consent of patients and their family members. Exclusion Criteria: * use of second-line chemotherapy regimen; * bilateral breast cancer; * inflammatory breast cancer; * pregnant or breast-feeding; * distant metastasis; * a history of other cancers or chest radiotherapy; * a history of abnormal blood test or other infectious symptoms.
References
Publications (0)
Data not yet available