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CDK4/6 Inhibitor

Abemaciclib + Elacestrant for Brain Metastasis Due to HR+/HER2- Breast Cancer(ELECTRA Trial)

Travesia da Choupana, Santiago De Compostela, Spain
Targeting 9 different conditionsElacestrant +1 morePhase 1 & 2RecruitingResearch Sponsored by Stemline Therapeutics, Inc.

ELECTRA Trial Summary

This trial is testing a new combination drug treatment for breast cancer that has spread to the brain. It is open to men and women with this type of breast cancer.

Eligible Conditions
  • Brain Tumor
  • Breast Disease
  • Breast Cancer
  • Tumors
  • Brain Diseases
  • Central Nervous System Disorders

ELECTRA Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

ELECTRA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate
RP2D
Secondary outcome measures
Clinical Benefit Rate
Duration of Progression-Free Survival
Duration of Tumor Response
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

ELECTRA Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment2 Interventions
Elacestrant in combination with abemaciclib at the recommended phase 2 dose (RP2D) determined in phase 1b
Group II: Phase 1b Cohort 3Experimental Treatment2 Interventions
Elacestrant 400 mg QD + abemaciclib 150 mg BID
Group III: Phase 1b Cohort 2Experimental Treatment2 Interventions
Elacestrant 400 mg QD + abemaciclib 100 mg BID
Group IV: Phase 1b Cohort 1Experimental Treatment2 Interventions
Elacestrant 300 mg once daily (QD) + abemaciclib 100 mg twice daily (BID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elacestrant
2015
Completed Phase 1
~80
Abemaciclib
2019
Completed Phase 2
~1440

Find a Location

Who is running the clinical trial?

Stemline Therapeutics, Inc.Lead Sponsor
17 Previous Clinical Trials
1,542 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05386108 — Phase 1 & 2
Brain Tumor Research Study Groups: Phase 1b Cohort 1, Phase 1b Cohort 2, Phase 1b Cohort 3, Phase 2
Brain Tumor Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT05386108 — Phase 1 & 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05386108 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still places available in this study for participants?

"Yes, if you visit clinicaltrials.gov you will see that this study is still looking for 106 patients at 1 location. The trial was first posted on 8/31/2022 and the most recent update was on 9/7/2022."

Answered by AI

What are the primary goals of this clinical trial?

"The primary outcome of this clinical trial, which will be measured over a 1 year time frame is to assess the efficacy of the drug combination of abemaciclib and elacestrant. Secondary outcomes include intracranial response rate per blinded independent central review (RECIST 1.1), intracranial response rate per blinded independent central review (RANO), and duration of progression free survival."

Answered by AI

How many test subjects are involved in this research?

"That is correct. The information available on clinicaltrials.gov indicates that the recruitment period for this trial is still open. This study was first announced on 8/31/2022 and has since been updated on 9/7/2022. They are looking to 106 individuals across 1 medical facility."

Answered by AI
~65 spots leftby Dec 2025