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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorOHSU Knight Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

Life expectancy of > 6 months, as determined by the investigator

Ability to understand and the willingness to sign a written informed consent document

Patients aged >= 18-100 years old at time of informed consent

Histologically or cytologically confirmed metastatic breast carcinoma

Disqualifiers

Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of first dose of 177Lu- DOTATATE treatment

Individuals in the follow-up phase of a prior investigational study may participate as long as it has been 4 weeks since last dose of the previous investigational agent or device

Prior external beam radiation therapy to more than 25% of the bone marrow

Other malignancy unless curatively treated with no evidence of disease for >= 5 years except: adequately treated non-melanoma skin cancer or curatively treated in situ cancer of the cervix

Trial design

Treatments tested in this trial

  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Gallium Ga 68-DOTATATE
  • Lutetium Lu 177 Dotatate
  • Positron Emission Tomography

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

OHSU Knight Cancer Institute

Lead sponsor

Advanced Accelerator Applications

Collaborator

Oregon Health and Science University

Collaborator

Novartis Pharmaceuticals

Collaborator