Selective Use of ALND in cT1-2N1 HR+/HER2- Breast Cancer Patients With 1 or 2 Positive Sentinel Lymph Nodes Undergoing Upfront Breast Surgery and Adjuvant Radiation: A Prospective Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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 only 1 or 2 affected lymph nodes, it will be possible to perform the less radical standard SLNB during surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients aged ≥18 years with biopsy-proven invasive breast cancer

• Patients with cT1 or T2 tumors with palpable ipsilateral mobile adenopathy of level I/II axillary nodes with biopsy-proven nodal metastasis (cN1) who are undergoing upfront surgery

• Patients with tumors of the HR+/HER2- subtype, defined as:

• HR+: Positive for estrogen receptor and/or progesterone receptor staining, indicated by ≥1% immunoreactive tumor nuclei

• 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

Locations
United States
Connecticut
Hartford Healthcare Cancer Alliance (Data collection only)
Recruiting
Hartford
New Jersey
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Recruiting
Middletown
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Pennsylvania
Lehigh Valley Health Network (Dara Collection Only)
Recruiting
Allentown
Contact Information
Primary
Anita Mamtani, MD
mamtana1@mskcc.org
646-888-6864
Backup
Monica Morrow, MD
646-888-5384
Time Frame
Start Date: April 20, 2021
Estimated Completion Date: April 2024
Participants
Target number of participants: 78
Treatments
Breast Cancer
Patients with cT1-2cN1 HR+/HER2- tumors who are scheduled to undergo upfront surgery will undergo in-house AUS to characterize suspicious-appearing lymph nodes, as is part of routine practice.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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