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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-07

Study Completion Date

2031-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Axillary Nodal Disease Female Breast Cancer Axilla; Breast Mastectomy; Lymphedema Tumor, Breast

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label, single arm

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

Breast Surgery (BCS or mastectomy) with TAD/SNB

Intervention Type PROCEDURE

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

Adjuvant Radiation Therapy

Intervention Type RADIATION

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

Interventions

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Breast Surgery (BCS or mastectomy) with TAD/SNB

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

Intervention Type PROCEDURE

Adjuvant Radiation Therapy

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No