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