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

Sponsor

Alice Chung (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06092892

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Axillary Nodal Disease Female Breast Cancer Axilla; Breast Mastectomy; Lymphedema Tumor, Breast	Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB Radiation: Adjuvant Radiation Therapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open label, single armOpen label, single arm

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2031

Anticipated Study Completion Date :

Jan 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm	Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy Radiation: Adjuvant Radiation Therapy Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy

Arm

Intervention/Treatment

Experimental: Single Arm

Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB

Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy

Radiation: Adjuvant Radiation Therapy

Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy

Outcome Measures

Primary Outcome Measures

Regional recurrence rate [5 Years]
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 [5 Years]
Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.
Disease-free survival (DFS) [5 Years]
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 [5 Years]
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) [5 Years]
Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Alice Chung

Investigators

Principal Investigator: Alice Chung, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alice Chung, Sponsor-Investigator, Cedars-Sinai Medical Center

ClinicalTrials.gov Identifier:

NCT06092892

Other Study ID Numbers:

IIT2023-09-Chung-UpfrontTAD

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 26, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alice Chung, Sponsor-Investigator, Cedars-Sinai Medical Center

T1-2N0 ER+ invasive

biopsy

upfront lumpectomy

Additional relevant MeSH terms:

Breast Neoplasms

Lymphedema

Study Results

No Results Posted as of Oct 26, 2023