Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Stemline Therapeutics, Inc.
435 participants
Jan 24, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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
Locations(118)
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NCT05563220