Clinical trial · Interventional
Evaluation Of Lymph Nodes After Neoadjuvant Chemotherapy
Evaluation Of Axillary Lymph Node Metastases With Sentinel Lymph Node Biopsy After Neoadjuvant Therapy In Breast Cancer Patients
NCT02752009CI-TRIAL-00030454withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The data that would be generated is no longer clinically novel.
Summary
Brief summary (as posted)
This research protocol is studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy).
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 |
|---|---|---|---|
| Axillary Lymph Node Sampling Clip | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Axillary Lymph Node Sampling Clip
- description
- * Axillary Lymph Node Biopsy \-- Axillary lymph node sampling with clip placement into the sampled lymph node. After the tissue sampling of any suspicious nodes, a marker clip will be placed to allow for intra-operative identification of the biopsied nodes. * Neoadjuvant therapy at the discretion of the treating Medical Oncologist. Once Neoadjuvant therapy is completed, surgery in the form of either Lumpectomy or Mastectomy is performed. * Wire-localization of the clipped node on the day of surgery. * Lymphatic mapping performed with either radiocolloid and/or blue dye. * Sentinel lymph node biopsy will be performed on the day of surgery. \--- If the clipped node which contains the wire is not part of this sentinel lymph node specimen, then it will be removed separately and be sent to Pathology as a separate specimen. * Axillary lymph node dissection as is the standard of care.
- interventionNames
- Procedure: Axillary Lymph Node Sampling Clip
Primary outcomes (1)
- measure
- False Negative Rate (FNR) Of Sentinel Lymph Node Biopsy At The Time Of Surgery
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible patients will include any patients with biopsy-proven breast cancer and biopsy-proven axillary lymph node metastases at Beth Israel Deaconess Medical Center who are candidates for Neoadjuvant Chemotherapy or Neoadjuvant Endocrine therapy. * A core needle biopsy or fine needle aspiration is acceptable for diagnosis of metastatic disease in lymph nodes. * Patients will be identified as possible participants in the Radiology Imaging suites and Breast Surgery Clinics. Exclusion Criteria: -Patients with inflammatory breast cancer or distant metastases will be excluded from participating in this study
References
Publications (0)
Data not yet available
No reference posted for this study.