NCT06092892 · Alice Chung
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
What this study 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 forward-looking, single treatment group$1 phase II clinical trial.
View original scientific description
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
Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Los Angeles, California
- Pasadena, California
- Tarzana, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations