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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04854005
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Breast surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Breast Cancer
Patients with cT1-2cN1 HR+/HER2- tumors who are scheduled to undergo upfront surgery will undergo AUS at the enrolling institution to characterize suspicious-appearing lymph nodes, as is part of routine practice.
 Procedure: Breast surgery
Patients will undergo SLNB with dual-tracer mapping with technetium-99m sulfur colloid and lymphazurin blue dye, in accordance with routine clinical practice.


Outcome Measures
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Primary Outcome Measures :
  1. evaluate rates of axillary lymph node dissection [ Time Frame: 2 years ]
    Completion ALND will be required if metastases are present in ≥3 SLNs on pathologic evaluation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential research subjects will be identified by a member of the patient's treatment team, the Principal Investigator (PI), or the research team at MSKCC/participating institutions.
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 (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 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854005


Contacts
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Contact: Anita Mamtani, MD 646-888-6864 mamtana1@mskcc.org
Contact: Monica Morrow, MD 646-888-5384

Locations
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United States, Connecticut
Hartford Healthcare Cancer Alliance (Data collection only) Recruiting
Hartford, Connecticut, United States, 06102
Contact: Niamey Wilson, MD    203-694-5200      
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Melissa Pilewskie, MD    734-647-8902      
United States, New Jersey
Memorial Sloan Kettering Basking Ridge (Consent Only) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Anita Mamtani, MD    646-888-6864      
Memorial Sloan Kettering Monmouth (All Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Anita Mamtani, MD    646-888-6864      
Memorial Sloan Kettering Bergen (Consent Only) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Anita Mamtani, MD    646-888-6864      
United States, New York
Memorial Sloan Kettering Suffolk - Commack (Consent Only) Recruiting
Commack, New York, United States, 11725
Contact: Anita Mamtani, MD    646-888-6864      
Memorial Sloan Kettering Westchester (Consent Only) Recruiting
Harrison, New York, United States, 10604
Contact: Anita Mamtani, MD    646-888-6864      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Anita Mamtani, MD    646-888-6864      
Principal Investigator: Anita Mamtani, MD         
Memorial Sloan Kettering Nassau (Consent Only) Recruiting
Uniondale, New York, United States, 11553
Contact: Anita Mamtani, MD    646-888-6864      
United States, Pennsylvania
Lehigh Valley Health Network (Dara Collection Only) Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Heiwon Chung, MD    610-402-7884      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Anita Mamtani, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04854005    
Other Study ID Numbers: 21-183
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Sentinel Lymph Node Biopsy
Palpable Node-Positive HR+/HER2
21-183
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases