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CDK4/6 Inhibitor
Abemaciclib + Elacestrant for Brain Metastasis from Breast Cancer (ELECTRA Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Stemline Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has adequate bone marrow and organ function, as defined by the following laboratory values: Absolute neutrophil count (ANC) ≥1.5 × 109/L, Platelets ≥100 × 109/L, Hemoglobin ≥9.0 g/dL, Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE Grade ≤1 (if screening assessments are abnormal, these assessments may be repeated up to 2 times; subjects may receive appropriate supplementation or treatment prior to reassessment), Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL/min, Serum albumin ≥3.0 g/dL (≥30 g/L), In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN. If the patient has liver metastases, ALT and AST ≤5 × ULN, Total serum bilirubin <1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN, The patient is able and willing to adhere to the study visit schedule and other protocol requirements
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. 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
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.
Who is the study for?
This trial is for men and women over 18 with brain metastases from ER-positive, HER-2 negative breast cancer. They must have had prior treatments including endocrine therapy and chemotherapy, be stable neurologically for at least 2 weeks, and not be breastfeeding or pregnant. Participants need to have good organ function and performance status, cannot have leptomeningeal metastases or imminent organ failure, and must agree to use effective contraception.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: Elacestrant and Abemaciclib in patients with brain metastasis due to hormone receptor-positive (HR+)/HER2-negative breast cancer. It's an open-label global study that will first determine the best dose (Phase 1b) followed by a larger test of effectiveness (Phase 2).See study design
What are the potential side effects?
Potential side effects may include fatigue, nausea, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems. Liver function abnormalities could occur as well as potential harm to unborn babies; hence contraception is required.
ELECTRA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Your blood, bone marrow, and organ functions are within normal range, and you are able and willing to attend all study appointments and follow the study's instructions.
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My cancer is ER-positive and HER-2 negative, confirmed by a test within the last 2 years.
Select...
I can take care of myself but might not be able to do heavy physical work.
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My cancer has worsened or returned after my last treatment.
ELECTRA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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 moreELECTRA 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
~1710
Find a Location
Who is running the clinical trial?
Stemline Therapeutics, Inc.Lead Sponsor
18 Previous Clinical Trials
1,779 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken elacestrant or similar drugs for my cancer.I have metastatic breast cancer and haven't received treatment, or it recurred within 12 months after my last treatment.I do not have any severe ongoing infections.Your blood, bone marrow, and organ functions are within normal range, and you are able and willing to attend all study appointments and follow the study's instructions.My cancer is ER-positive and HER-2 negative, confirmed by a test within the last 2 years.I can take care of myself but might not be able to do heavy physical work.My brain-related symptoms have been stable for at least 2 weeks.I am a woman who is either postmenopausal, premenopausal, or perimenopausal.I have not had major surgery in the last 4 weeks.My brain cancer has not been treated before, is growing, or is outside previously treated areas.I agree to use effective birth control methods if I can have children.I've been on a stable or decreasing dose of corticosteroids, not exceeding 4 mg of dexamethasone daily, for over a week.My cancer has worsened or returned after my last treatment.I may have brain metastases for Phase 1b, but must have at least one measurable brain metastasis for Phase 2.I am not pregnant or breastfeeding.My cancer has spread to the lining of my brain and spinal cord.My doctor thinks I'll need treatment for my brain soon.I am experiencing a severe health crisis due to organ failure.I cannot take pills by mouth or have a condition that affects how my body absorbs food.I have hepatitis B/C or HIV with an undetectable viral load.I agree to use effective birth control and not donate sperm during and for 120 days after treatment.I haven't taken any cancer drugs or been in a drug study recently.I haven't had cancer, except for certain skin, bladder, cervical, or a second breast cancer, in the last 3 years.I've had hormone therapy, up to 2 chemotherapies, and CDK 4/6 inhibitors (not abemaciclib) for my metastatic cancer.I am not currently receiving treatment in another breast cancer study.I am 18 years old or older.I have previously been treated with abemaciclib for cancer that has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b Cohort 1
- Group 2: Phase 1b Cohort 2
- Group 3: Phase 1b Cohort 3
- Group 4: Phase 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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