NCT04529044

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

A Phase II Pilot Study of (Lutetium (177Lu)-DOTATATE in Patients With Metastatic Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. Assess objective response in study participants receiving lutetium Lu 177 dotatate (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. 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. Patients also receive gallium (Ga) 68-DOTATATE and undergo positron emission tomography/computed tomography (PET/CT) during screening, biopsy as clinically-indicated as well as CT and/or magnetic resonance imaging (MRI) and collection of blood samples throughout the study. After completion of study treatment, patients are followed up every 3 months for up to 5 years.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Breast Carcinoma
• Recurrent Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Computed Tomography	Undergo PET/CT
RADIATION	Gallium Ga 68-DOTATATE	Receive 68Ga
DRUG	Lutetium Lu 177 Dotatate	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-20
• Completion: 2026-12-20
• First posted: 2020-08-27
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study