IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
Recruiting · NCT06092892 · Interventional (participants receive a specific treatment) · Lead sponsor: Alice Chung
View the official record on ClinicalTrials.gov →Interventions studied
Adjuvant Radiation TherapyBreast Surgery (BCS or mastectomy) with TAD/SNB
What this trial is 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.
Who can take part
Age range
45 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
3 locations listed across 1 US state.
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute - Los Angeles, California, United States
- CS Cancer at Huntington Cancer Center - Pasadena, California, United States
- CS Cancer at Valley Oncology Medical Group - Tarzana, California, United States