Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lutetium Lu 177 Dotatate · 1 trial · 3 indications
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...
Lutetium Lu 177 Dotatate is being studied for the treatment of Anatomic Stage IV Breast Cancer AJCC v8, including metastatic and recurrent breast carcinoma. It is an investigational small molecule in Phase 2 clinical development, and it is not yet approved for this indication.
Lutetium Lu 177 Dotatate targets the somatostatin receptor (SSTR), a receptor class target. By binding to SSTR, the drug is designed to deliver radiation to cells expressing this receptor, which is relevant in certain breast cancer tumors.
Lutetium Lu 177 Dotatate is being developed by Novartis AG, traded on the stock exchange under the ticker NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with stage IV breast cancer.
Lutetium Lu 177 Dotatate is currently in Phase 2 clinical development for Anatomic Stage IV Breast Cancer AJCC v8. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being tested in clinical trials.
Lutetium Lu 177 Dotatate is being evaluated in a Phase 2 clinical trial with the identifier NCT04529044, titled '177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer'. This single-arm, uncontrolled study is recruiting participants in the United States and aims to enroll 10 patients.