Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Conditions

• Breast Cancer
• Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Elacestrant — DRUG
  Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days
• Alpelisib — DRUG
  Alpelisib 150 mg or 250 mg once daily in cycles of 28 days
• Everolimus — DRUG
  Everolimus 5 mg, 7.5 mg, or 10 mg once daily in cycles of 28 days
• Ribociclib — DRUG
  Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days
• Palbociclib — DRUG
  Palbociclib 100 mg or 125 mg once daily for 21 days followed by 7 days off in cycles of 28 days
• Capivasertib — DRUG
  Capivasertib 200 mg or 320 mg or 400 mg twice daily for 4 days on, 3 days off in cycles of 28 days
• Abemaciclib — DRUG
  Abemaciclib 100 mg or 150 mg twice daily in cycles of 28 consecutive days

Study Details

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.

Key Dates

Start date

Jan 24, 2023

Status verified

Jan 2026

Primary completion

Dec 27, 2026

Completion

Dec 28, 2028

Study Design

Enrollment

435 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1b Arm A: elacestrant with alpelisib
  Elacestrant Dihydrochloride 300 milligrams (mg) or 400 mg + Alpelisib 150 mg to 250 mg
• Experimental: Phase 1b Arm B: elacestrant with everolimus
  Elacestrant Dihydrochloride 300 mg or 400 mg + Everolimus 5.0 mg, 7.5 mg or possibly 10 mg
• Experimental: Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:
  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)
• Experimental: Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i)
  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
• Experimental: Phase 1b Arm E:
  Elacestrant Dihydrochloride 300 mg, 400 mg + Capivasertib 200 mg, 320 mg, 400 mg

Primary Outcome Measure

Number of Participants with DLTs Observed During the First Cycle [ Time Frame: 28 days ]

Central Contacts

• Stemline Trials
  1-877-332-7961
  [email protected]

Locations (45)

Find similar trials in Dothan, AL

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