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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02752009
Enrollment
0
Registered
2016-04-26
Start date
2016-04-26
Completion date
2016-12-21
Last updated
2017-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Armpit lymph nodes Cancer

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).

Detailed description

* This research study is a Pilot Study, which is the first time investigators are examining this study intervention locally; although this intervention has been studied nationally in published clinical trials. * In this research study, the investigators are 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). * A sentinel lymph node biopsy is a surgical evaluation of the lymph nodes in the underarm area in patients who have early breast cancer. Approximately, two-five nodes are removed from the underarm area for evaluation. The sentinel lymph node biopsy is performed in patients with breast cancer to determine if there are cancer cells in the lymph nodes in the armpit. * The sentinel lymph node biopsy procedure is performed by injecting one or two dyes into the breast, which then travel to the armpit region via small vessels in the immune system. These nodes are called the sentinel lymph nodes. They represent the first nodes that drain the breast tissue. They are closely evaluated by a Pathologist to determine if cancer cells are present. * This information allows physicians to know how far the cancer may have spread and recommend therapies accordingly. * If sentinel lymph node biopsy is determined to be accurate in patients who are known to already have cancer cells in the axillary lymph nodes who receive neoadjuvant therapy, then in the future, many of the patients in this population may be spared the procedure of a full axillary lymph node dissection, which removes a larger number of lymph nodes and thus has increased risks and side-effects.

Interventions

PROCEDUREAxillary Lymph Node Sampling Clip

Sponsors

Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
False Negative Rate (FNR) Of Sentinel Lymph Node Biopsy At The Time Of Surgery2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026