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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age45+
SponsorAlice Chung

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Treatments tested in this trial

  • Breast Surgery (BCS or mastectomy) with TAD/SNB
  • Adjuvant Radiation Therapy

Treatment groups

45 Participants
are divided into 1 treatment group

Sponsors and collaborators

Alice Chung

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution