Clinical trial · Observational
Sentinel Lymph Node Biopsy in Clinically Node-negative Early Breast Cancer Patients After Neoadjuvant Chemotherapy
NCT03381092CI-TRIAL-00055268unknownClinicalTrials.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)
This is a prospective, single-center, non-randomized, non-controlled observational study.
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 |
|---|---|---|---|
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- invasive breast cancer
- description
- Patients with invasive breast cancer who have clinically negative axilla and receive neoadjuvant treatment followed by sentinel lymph node biopsy are eligible for this study.
Primary outcomes (1)
- measure
- Positive Rate of Axillary Sentinel Lymph Nodes.
- timeFrame
- Within 6 weeks after obtaining the post-surgery pathological results.
- description
- Positive rate of axillary sentinel lymph nodes in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.
Secondary outcomes (4)
- measure
- Detection Rate of Axillary Sentinel Lymph Nodes.
- timeFrame
- Within 6 weeks after obtaining the post-surgery pathological results.
- description
- Detection rate of axillary sentinel lymph nodes in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Invasive breast cancer diagnosed with core needle needle biopsy; * Staging cT1b-2N0M0; * ER/PR positive cells ratio \<10%, or HER2 positive (according to ASCO-CAP guidelines),and with chemotherapy indications; * Without chemotherapy contraindications, and planned or has started neoadjuvant chemotherapy (HER2 positive breast cancer neoadjuvant anti-HER2 treatment, or have adjuvant anti-HER2 treatment plan); * With axillary sentinel lymph node biopsy indications confirmed prior to neoadjuvant therapy; * Voluntarily join the study and sign an informed consent form. Exclusion Criteria: * History of malignant tumors. * With chemotherapy contraindications. * Recieved any form of surgery of primary tumor or axillary lymph nodes. * Refuse neoadjuvant chemotherapy. * Refuse assessment examinations. * Refuse to join the study.
References
Publications (0)
Data not yet available
No reference posted for this study.