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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Undergo biopsy
Undergo collection of blood samples
Undergo PET/CT
Receive 68Ga
Given IV
Undergo PET/CT
OHSU Knight Cancer Institute
Portland, Oregon, United States
RECRUITINGObjective 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).
Time frame: Up to 3 months post-therapy
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).
Time frame: Up to 3 months post-therapy
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.
Time frame: Up to 12 months post-therapy
Progression-free survival
PFS will be plotted using a Kaplan-Meier curve and reported with median survival and a 95% CI.
Time frame: Up to 12 months post-therapy
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.
Time frame: Up to 3 months post-therapy
Duration of stable disease
Time frame: Up to 12 months post-therapy
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