Clinical trial · Interventional
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neoadjuvant Therapy
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neo-adjuvant Therapy : a Prospective Randomized Control Trial.
NCT05838001CI-TRIAL-00078464unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 standard method for localizing non-palpable breast cancer is currently clip localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of single vs. combined breast tissue markers in localizing non-palpable breast cancer.
Conditions
Conditions (2)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast-conserving Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| marker clip localization | Procedure | — | UNRESOLVED |
| Wire-guided localization and marker clip localization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- patients after neoadjuvant therapy-combined localization
- interventionNames
- Procedure: Wire-guided localization and marker clip localization
- type
- ACTIVE_COMPARATOR
- label
- patients after neoadjuvant therapy-single localization
- interventionNames
- Procedure: marker clip localization
Primary outcomes (1)
- measure
- Marginal positive rate
- timeFrame
- up to 3 months
- description
- Proportion of patients with positive margin (intraoperative freezing and postoperative pathological margin tissue showing cancer)
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. female patients, age≥18 year 2. A score of ≥ 2 on the Eastern Cooperative Oncology Group scale 3. Patients pathologically diagnosed with breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment. 4. Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery Exclusion Criteria: 1. Inflammatory breast cancer or Paget's disease 2. Breast deformities and other conditions that impact breast conservation success rate 3. Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded. 4. Pregnancy or lactation 5. Patients with hook-wire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment 6. Patients with stage IV diseases or unresectable lesions in either breast 7. Patients combined with other diseases that may affect survival 8. Patients with multicentric breast cancer lesions or lesions \> 5 cm in diameter on imaging examinations 9. Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy 10. Patients with history of ipsilateral breast cancer radical mastectomy or chest wall radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.