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.
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
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
Single group
Biopsy
Procedure/SurgeryUndergo biopsy
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Gallium Ga 68-DOTATATE
RadiationReceive 68Ga
Lutetium Lu 177 Dotatate
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Objective response rate (ORR)
Using the intent to treat (ITT) set and the efficacy analysis set, each ORR will be reported as a point estimate along with a 2-sided 95% exact confidence interval (CI).
Disease control rate (DCR)
A point estimate and 2-sided 95% CI will be provided for the DCR, defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD) (as assessed by the investigator per Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\]1.1).
Duration of response (DOR)
DOR will be estimated on responding participants and plotted with cumulative incidence functions: one curve for the first occurrence of recurrence, progression, or disease-related death and one curve for deaths in the absence of disease recurrence or progression.
Progression-free survival
PFS will be plotted using a Kaplan-Meier curve and reported with median survival and a 95% CI.
Incidence of adverse events (AEs)
The severity of the AE will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Study drug-related AEs are those assessed by investigator as definitely or probably related. Using the safety analysis set, the incidence of treatment emergent adverse events (TEAEs) and non-treatment-related AEs will be determined for study participants who receive at least one dose of lutetium Lu 177 dotatate (177Lu- DOTATATE). The point estimate and 95% CI will be reported for overall toxicities as well as for each major organ category.
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OHSU Knight Cancer Institute
Lead sponsor
Advanced Accelerator Applications
Collaborator
Oregon Health and Science University
Collaborator
Novartis Pharmaceuticals
Collaborator
