177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer

This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2. 177Lu-DOTATATE is a targeted therapy that uses DOTATATE, linked to a radioactive agent called 177Lu. DOTATATE attaches to tumor cells with SSTR2 and delivers 177Lu to kill them. Giving 177Lu-DOTATATE may help decrease the number and size of tumors and the number of circulating cancer stem cells in patient's blood for the treatment of patients with breast cancer positive for SSTR2.

NCT Number	NCT04529044
Lead Sponsor	OHSU Knight Cancer Institute Collaborators: Advanced Accelerator Applications, Oregon Health and Science University, Novartis Pharmaceuticals
Conditions	Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma
Enrollment	10 participants
Start Date	2026-06-30
Primary Completion	2027-12-20 (estimated)
Study Completion	2027-12-20 (estimated)
Updated on ClinicalTrials.gov	2026-06-05