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

Alice Chung

Status and phase: Enrolling; Phase 2

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

Treatments: Radiation: Adjuvant Radiation Therapy; Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB

Study type: Interventional

Funder types: Other

Identifiers

NCT06092892

IIT2023-09-Chung-UpfrontTAD

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Single Arm

Experimental group

Treatment:

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

Radiation: Adjuvant Radiation Therapy