Breast Cancer Clinical Trial

Use of Sentinel Lymph Node Biopsy in Patients With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Upfront Surgery and Adjuvant Radiation

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with occult primary breast cancer
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 is for people with:

Breast Cancer

Estimated Enrollment:

78

Study ID:

NCT04854005

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 3 Locations for this study

See Locations Near You

Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown New Jersey, 07748, United States More Info
Anita Mamtani, MD
Contact
646-888-6864
[email protected]
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Anita Mamtani, MD
Contact
646-888-6864
Anita Mamtani, MD
Principal Investigator
Lehigh Valley Health Network (Dara Collection Only)
Allentown Pennsylvania, 18103, United States More Info
Heiwon Chung, MD
Contact
610-402-7884

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

78

Study ID:

NCT04854005

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

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