At a glance
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A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
In Brief
A Phase 1 clinical trial evaluating Elacestrant, Alpelisib, and 5 other interventions for Breast Cancer and Metastatic Breast Cancer. Active but no longer recruiting, targeting 435 participants across 83 sites in 13 countries.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Elacestrant Dihydrochloride 300 milligrams (mg) or 400 mg + Alpelisib 150 mg to 250 mg
Elacestrant Dihydrochloride 300 mg or 400 mg + Everolimus 5.0 mg, 7.5 mg or possibly 10 mg
Elacestrant Dihydrochloride 100 mg, 200 mg, 300 mg + Ribociclib 400 mg or possibly 600 mg The RP2D for the combination of elacestrant and abemaciclib is evaluated in the ongoing ELECTRA trial (ClinicalTrials.gov Identifier: NCT04791384)
Elacestrant Dihydrochloride 300 mg or 400 mg + Palbociclib 100 mg,125 mg or the RP2D for the combination of elacestrant and abemaciclib is evaluated in the ongoing ELECTRA trial (ClinicalTrials.gov Identifier: NCT04791384) Elacestrant 86 mg, 172 mg, 258 mg + Ribociclib 400 mg or possibly 600 mg
Elacestrant Dihydrochloride 300 mg, 400 mg + Capivasertib 200 mg, 320 mg, 400 mg
Interventions
Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days
Alpelisib 150 mg or 250 mg once daily in cycles of 28 days
Everolimus 5 mg, 7.5 mg, or 10 mg once daily in cycles of 28 days
Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days
Palbociclib 100 mg or 125 mg once daily for 21 days followed by 7 days off in cycles of 28 days
Capivasertib 200 mg or 320 mg or 400 mg twice daily for 4 days on, 3 days off in cycles of 28 days
Abemaciclib 100 mg or 150 mg twice daily in cycles of 28 consecutive days