TheranosticTrials.org

Clinical Trial · NCT04529044

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

Overview

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.

Sponsor

OHSU Knight Cancer Institute

Phase

Phase 2

Contacts

Kaiya R Kozuma (CONTACT)

kozuma@ohsu.edu

7024672457

Rodney F Pommier (CONTACT)

pommierr@ohsu.edu

5034945501

ClinicalTrials.gov

NCT04529044

Drug / Compound

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Ability to understand and the willingness to sign a written informed consent document
  • Stage IV or recurrent disease with distant metastases
  • * Life expectancy of \> 6 months, as determined by the investigator
  • Histologically or cytologically confirmed metastatic breast carcinoma
  • Patients aged \>= 18-100 years old at time of informed consent

Exclusion

  • * 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
  • Known brain metastases, unless these metastases have been treated and stabilized
  • 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