drugset / Trial / NCT05563220
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.
Timeline
- Start
- 2023-01-24
- Primary completion
- 2026-12-27
- Completion
- 2028-12-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 100 mg | — |
| Subject | Abemaciclib | Small molecule | 150 mg | — |
| Subject | Alpelisib | Small molecule | 150 mg | — |
| Subject | Alpelisib | Small molecule | 250 mg | — |
| Subject | Capivasertib | Small molecule | 200 mg | — |
| Subject | Capivasertib | Small molecule | 320 mg | — |
| Subject | Capivasertib | Small molecule | 400 mg | — |
| Subject | Elacestrant | Other / unclassified | 86 mg | — |
| Subject | Elacestrant | Other / unclassified | 100 mg | — |
| Subject | Elacestrant | Other / unclassified | 172 mg | — |
| Subject | Elacestrant | Other / unclassified | 200 mg | — |
| Subject | Elacestrant | Other / unclassified | 258 mg | — |
| Subject | Elacestrant | Other / unclassified | 300 mg | — |
| Subject | Elacestrant | Other / unclassified | 345 mg | — |
| Subject | Elacestrant | Other / unclassified | 400 mg | — |
| Subject | Everolimus | Small molecule | 5 mg | — |
| Subject | Everolimus | Small molecule | 7.5 mg | — |
| Subject | Everolimus | Small molecule | 10 mg | — |
| Subject | Palbociclib | Small molecule | 100 mg | — |
| Subject | Palbociclib | Small molecule | 125 mg | — |
| Subject | Ribociclib | Small molecule | 400 mg | — |
| Subject | Ribociclib | Small molecule | 600 mg | — |