About this trial
This study looks at women with early-stage, hormone-sensitive breast cancer that has spread to nearby lymph nodes. The goal is to understand how well upfront surgery followed by radiation therapy works. Researchers will track the chance the cancer comes back and how patients are doing over time. This is a Phase 2 trial, meaning it's testing how well this treatment works and how safe it is.
The trial's ID number is NCT06092892. It is a Phase 2 study, which means it is testing the effectiveness and safety of the treatment. The study is not looking at FDA-regulated drugs or devices and hopes to include about 45 participants.
Who can join
Women aged 45 and older can join if they have specific types of breast cancer with lymph node involvement. Some criteria may prevent participation, like having certain types of cancer or too many suspicious nodes. The trial team will confirm eligibility for each participant.
Conditions
Breast Cancer, Axillary Nodal Disease, Female Breast Cancer, Axilla; Breast, Mastectomy; Lymphedema, Tumor, Breast
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will all receive the same treatment, which includes surgery (either lumpectomy or mastectomy) with a procedure to check the lymph nodes, followed by radiation therapy. Everyone in the trial is in one group, so there is no random assignment to different treatments.
Where
This trial is running at 3 locations in the United States. All of them are currently recruiting.
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California
CS Cancer at Huntington Cancer Center
Pasadena, California
CS Cancer at Valley Oncology Medical Group
Tarzana, California