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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT04529044
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Dec 20, 2027
Completion
Dec 20, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (177Lu-DOTATATE)
    Patients receive 177Lu-DOTATATE IV over 30-40 minutes during weeks 1, 8, 16, and 24 in the absence of disease progression or unacceptable toxicity. Patients also receive Ga 68-DOTATATE and undergo PET/CT during screening, biopsy as clinically-indicated as well as CT and/or MRI and collection of blood samples throughout the study.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 3 months post-therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Rodney Pommier
[email protected]
(503) 494-5501
Rodney Pommier (PRINCIPAL_INVESTIGATOR)

Find similar trials in Portland, OR

By research site
OHSU Knight Cancer Institute· Portland, OR

Related Studies