Clinical trial · Interventional
Feasibility in Identification of Breast Cancer Candidates for Elimination of Axillary Surgery
Feasibility in Identification of Suitable Candidates for Elimination of Axillary Surgery in Breast Cancer Patients With Initial Biopsy-confirmed Nodal Metastases
NCT05663021CI-TRIAL-00062866completedN/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)
Preoperative identification of patients with pathologic complete response or residual disease in axilla can aid in tailoring subsequent axillary surgery including omission of axillary surgery based on tumor biology and response to neoadjuvant chemotherapy.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound-guided core needle biopsy in breast | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ultrasound-Guided Biopsy of Tumor Site during neoadjuvant chemotherapy
- description
- For patients who were not evaluated as progressive disease by the latest imaging measurement, repeated CNB (RCNB) was performed after 2-4 cycles of NAC, depending on the total cycles of NAC. Tissue is acquired from different sections of the lesion from different angles to minimize the impact of tumor heterogeneity. For each patient, 3 to 4 tissue specimens are collected and sent for pathological review to examine whether there is residual malignancy (residual cancer, pleomorphic tissue) in the tumor site that is tattooed.
- interventionNames
- Diagnostic Test: Ultrasound-guided core needle biopsy in breast
Primary outcomes (1)
- measure
- Diagnostic Accuracy of Ultrasound-Guided Core Biopsy of Initial Breast Cancer Region Compared to Axillary Surgery with Pathologic Evaluation Cancer Region Compared to Standard Surgery with Pathologic Evaluation
- timeFrame
- 1 day
- description
- Accuracy of core biopsy determined by biopsy results to the axillary pathologic evaluation removed during standard surgery. Estimates and 95% confidence intervals for accuracy, sensitivity, false negative rate (FNR), specificity as well as the negative predictive value (NPV) reported for FNA and core biopsy based on the exact Clopper-Pearson method.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical stage T1-4 N1-3M0 breast cancer at diagnosis (prior to neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition 2. Aged above 18 and below 70 years 3. No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix 4. Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry \[IHC\] and/or in situ hybridization \[ISH\]) evaluated on core needle biopsy prior to starting neoadjuvant chemotherapy 5. Completing all planned cycles and regimens of neoadjuvant chemotherapy followed by axillary surgery Exclusion Criteria: 1. Nonrepresentative core needle biopsy in the breast during neoadjuvant chemotherapy 2. Inflammatory breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.