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IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases

Primary Purpose

Breast Cancer, Axillary Nodal Disease, Female Breast Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Breast Surgery (BCS or mastectomy) with TAD/SNB and Adjuvant Radiation Therapy
Sponsored by
Alice Chung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring T1-2N0 ER+ invasive, biopsy, upfront lumpectomy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women age ≥ 45 Clinical T1-2N0 ER+ invasive breast cancer US detected biopsy proven axillary nodal disease Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Palpable nodes on physical exam Her2+ or ER- invasive breast cancer Extranodal extension > 3 mm on nodal biopsy More than 2 suspicious nodes on preoperative imaging

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single Arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    Regional recurrence rate
    Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.

    Secondary Outcome Measures

    Local recurrence rate
    Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.
    Disease-free survival (DFS)
    Disease-free survival (DFS) is defined as the length of time after targeted axillary dissection (TAD) that the subject survives without any signs or symptoms of breast cancer.
    Breast cancer specific survival (BCSS) rate
    Breast cancer specific survival (BCSS) rate is defined as the percentage of subjects who have not died from breast cancer during follow-up period
    Overall survival (OS)
    Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.

    Full Information

    First Posted
    October 16, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Alice Chung
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06092892
    Brief Title
    IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
    Official Title
    IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    January 2031 (Anticipated)
    Study Completion Date
    January 2031 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Alice Chung

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Axillary Nodal Disease, Female Breast Cancer, Axilla; Breast, Mastectomy; Lymphedema, Tumor, Breast
    Keywords
    T1-2N0 ER+ invasive, biopsy, upfront lumpectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    Open label, single arm
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Arm
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Breast Surgery (BCS or mastectomy) with TAD/SNB and Adjuvant Radiation Therapy
    Intervention Description
    Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy
    Primary Outcome Measure Information:
    Title
    Regional recurrence rate
    Description
    Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.
    Time Frame
    5 Years
    Secondary Outcome Measure Information:
    Title
    Local recurrence rate
    Description
    Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.
    Time Frame
    5 Years
    Title
    Disease-free survival (DFS)
    Description
    Disease-free survival (DFS) is defined as the length of time after targeted axillary dissection (TAD) that the subject survives without any signs or symptoms of breast cancer.
    Time Frame
    5 Years
    Title
    Breast cancer specific survival (BCSS) rate
    Description
    Breast cancer specific survival (BCSS) rate is defined as the percentage of subjects who have not died from breast cancer during follow-up period
    Time Frame
    5 Years
    Title
    Overall survival (OS)
    Description
    Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.
    Time Frame
    5 Years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women age ≥ 45 Clinical T1-2N0 ER+ invasive breast cancer US detected biopsy proven axillary nodal disease Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Palpable nodes on physical exam Her2+ or ER- invasive breast cancer Extranodal extension > 3 mm on nodal biopsy More than 2 suspicious nodes on preoperative imaging
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clinical Trial Navigator
    Phone
    3104232133
    Email
    cancer.trial.info@cshs.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alice Chung, MD
    Organizational Affiliation
    Cedars-Sinai Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases

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