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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

Tracking Information
First Submitted Date April 20, 2021
First Posted Date April 22, 2021
Last Update Posted Date May 20, 2021
Actual Study Start Date April 20, 2021
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 20, 2021)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Breast Cancer
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Procedure: Breast-conserving surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 20, 2021)
147
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2024
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Breast cancer
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Anita Mamtani, MD 646-888-6864 mamtana1@mskcc.org
Contact: Monica Morrow, MD 646-888-5384
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04854005
Other Study ID Numbers 21-183
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Anita Mamtani, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date May 2021