Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04529044 | 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer | PHASE2 | RECRUITING | 10 | — | — | Jun 30, 2026 | Dec 20, 2027 | Jun 5, 2026 | 1 | United States |
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).
| Arm | Type | Description |
|---|---|---|
| Treatment (177Lu-DOTATATE) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: * 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 bre...