drugset / Trial / NCT04862143
Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant
NaSingle-groupOpen-labelTreatment
Summary
The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.
Timeline
- Start
- 2022-03-08
- Primary completion
- 2022-09-19
- Completion
- 2022-09-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | 300 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Background | Goserelin | Other / unclassified | 3.6 mg | Intramuscular |