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A Study of the Use of Sentinel Lymph Node Biopsy in Women With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Breast Conservation Therapy

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ClinicalTrials.gov Identifier: NCT04854005
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to find out how often the researchers can avoid an ALND in women with early-stage, node-positive HR+/HER2- breast cancer who are having breast-conserving treatment. 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 breast-conserving surgery.

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

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Study Type : Observational
Estimated Enrollment : 147 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 Conservation: 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

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




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast cancer
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.
Criteria

Inclusion Criteria:

  • Female 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 BCS
  • 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)

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, New York
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         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Anita Mamtani, MD Memorial Sloan Kettering Cancer Center
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: May 20, 2021
Last Verified: May 2021
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
Breast Conservation Therapy
21-183
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases