Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial
Official title:
A Phase II Pilot Study of (Lutetium (177Lu)-DOTATATE in Patients With Metastatic 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.
PRIMARY OBJECTIVE: I. Assess objective response in study participants receiving lutetium Lu 177 tetra-azacyclododecanetetra-acetic acid (dota) tyr3-octreotate (tate) (177Lu-DOTATATE) therapy. SECONDARY OBJECTIVES: I. Assess the rate of disease control following 177Lu-DOTATATE therapy. II. Evaluate duration of treatment response to 177Lu-DOTATATE. III. Assess progression-free survival (PFS). IV. Assess safety and tolerability of the 177Lu-DOTATATE therapy. V. Evaluate over time the requirements for stable disease. EXPLORATORY OBJECTIVES: I. Evaluate changes in the number of circulating SSTR2+ breast cancer cells (including cancer stem cell sub-populations) following 177Lu-DOTATATE treatment. II. Assess changes in gene profile among SSTR2+ breast cancer cells following 177Lu-DOTATATE treatment. OUTLINE: Patients receive 177Lu-DOTATATE intravenously (IV) over 30-40 minutes during weeks 1, 8, 16, and 24 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 5 years. ;
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