drugset / Trial / NCT05101564
Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer
Phase 2
Completed
19 enrolled
Jennifer Lee Caswell-Jin
Effector Therapeutics · collabNovartis Pharmaceuticals · collabUnited States Department of Defense · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used to treat this type of breast cancer. Different therapies are being tested based on the specific gene changes in the tumor. Not every tumor will have a gene change that is being studied.
Timeline
- Start
- 2023-03-20
- Primary completion
- 2024-06-03
- Completion
- 2024-06-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | 300 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Tamoxifen | Small molecule | 20 mg | Oral |
| Subject | Zotatifin | Small molecule | 0.1 mg/kg | Intravenous |