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Recruiting NCT06092892

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

Phase II Interventional Breast Cancer Axillary Nodal Disease Female Breast Cancer Axilla; Breast

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breast Surgery (BCS or mastectomy) with TAD/SNB, Adjuvant Radiation Therapy.
Who it may be relevant to
Registry conditions: Breast Cancer, Axillary Nodal Disease, Female Breast Cancer, Axilla; Breast. Basic parameters: from 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Regional recurrence rate [Time frame: 5 Years]
Secondary outcome measures (4)
  • Local recurrence rate [Time frame: 5 Years]
  • Disease-free survival (DFS) [Time frame: 5 Years]
  • Breast cancer specific survival (BCSS) rate [Time frame: 5 Years]
  • Overall survival (OS) [Time frame: 5 Years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles
  • CS Cancer at Huntington Cancer Center — Pasadena
  • CS Cancer at Valley Oncology Medical Group — Tarzana

Identifiers

NCT: NCT06092892 · IIT2023-09-Chung-UpfrontTAD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗