Selective Use of ALND in N1 HR+/HER2- Breast Cancer Patients With 1 or 2 Positive Sentinel Lymph Nodes Undergoing Upfront Breast Surgery and Adjuvant Radiation: A Prospective Study
Data Collection
Collected from today forward - ProspectiveBreast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 20, 2021
Actual date on which the first participant was enrolled.The purpose of this study is to find out how often the researchers can avoid an ALND in patients with early-stage, node-positive HR+/HER2- breast cancer who are having upfront surgery. The study researchers think that, if AUS before surgery can help identify people who may have up to 3 affected lymph nodes, it will be possible to perform the less radical standard SLNB during surgery.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.78 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients aged ≥18 years with biopsy-proven invasive breast cancer * Patients with cTx, cT1, or cT2 tumors with palpable ipsilateral mobile adenopathy of level I/II axillary nodes with biopsy-proven (either by pre-operative biopsy or intraoperative frozen section) nodal metastasis (cN1) who are undergoing upfront surgery * Patients with tumors of the HR+/HER2- subtype, defined as: 1. HR+: Positive for estrogen receptor and/or progesterone receptor staining, indicated by ≥1% immunoreactive tumor nuclei 2. HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay Exclusion Criteria: * Patients with prior ipsilateral breast cancer * Patients who are pregnant * Patients with stage IV disease at presentation * Patients with advanced regional disease (cN2/cN3)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
Hartford Healthcare Cancer Alliance (Data collection only)
Hartford, United StatesOpen Hartford Healthcare Cancer Alliance (Data collection only) in Google MapsUniversity of Michigan (Data Collection Only)
Ann Arbor, United StatesMemorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, United StatesMemorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, United States