← Back to Search

CDK4/6 Inhibitor

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

Q: 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.

Q: 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.

Q: 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.

Travesia da Choupana, Santiago De Compostela, Spain

Targeting 9 different conditionsElacestrant +1 morePhase 1 & 2RecruitingResearch Sponsored by Stemline Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ER and HER-2 testing must be performed in the following manner: Documentation of ER positive tumor with ≥ 1% staining by immunohistochemistry (IHC) as defined in the 2010 or 2020 American Society for Clinical Oncology (ASCO) recommendations for ER testing, with or without progesterone receptor (PGR) positivity HER-2 negative tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2013 or 2018 ASCO recommendations for HER-2 testing Patients receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 7 days prior to baseline and not receiving doses higher than 4 mg of dexamethasone per day or equivalent. Any neurological symptoms of brain metastases must be stable for at least 2 weeks before starting trial therapy.

Female patients may be either postmenopausal or premenopausal or perimenopausal. Postmenopausal status is defined by: Age ≥60 years Age <60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value <40 pg/mL (140 pmol/L) or in postmenopausal ranges per local reference ranges Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy). Patient must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing either from a fresh biopsy or from an archival tissue obtained no more than 2 years prior to signing of the informed consent form.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up3 years

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

0 / 2Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/HER2- Breast Cancer

2022. "Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/HER2- Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05386108.

All > Brain Metastases > Brain Tumor