Evaluation Of Lymph Nodes After Neoadjuvant Chemotherapy

NCT02752009 | Withdrawn DMC

• 1 other identifier: 15-494
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer

Keywords

Breast Cancer; Armpit lymph nodes Cancer

Outcome Measures

Primary Outcomes (1)

• False Negative Rate (FNR) Of Sentinel Lymph Node Biopsy At The Time Of Surgery

  2 years

Study Arms (1)

Axillary Lymph Node Sampling Clip

EXPERIMENTAL

* 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.

Procedure: Axillary Lymph Node Sampling Clip

Interventions

Axillary Lymph Node Sampling Clip PROCEDURE

Axillary Lymph Node Sampling Clip

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with inflammatory breast cancer or distant metastases will be excluded from participating in this study

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ranjna Sharma, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ranjna Sharma, M.D

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 26, 2016
• Study Start: April 26, 2016
• Primary Completion: December 21, 2016
• Study Completion: December 21, 2016
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share