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Selective Estrogen Receptor Degrader (SERD)
Elacestrant Combinations for Breast Cancer (ELEVATE 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests multiple drug combos to find the safest & most effective for treating ER+/HER2- advanced/metastatic breast cancer.
Who is the study for?
This trial is for adults with ER+/HER2- advanced/metastatic breast cancer who've had up to two hormonal therapies, one with a CDK4/6 inhibitor. They must have good organ function and performance status, no severe allergies to the drugs being tested, and agree to contraception if of childbearing potential. Those with certain prior treatments or health conditions are excluded.
What is being tested?
The study tests Elacestrant in combination with other cancer drugs (Alpelisib, Everolimus, Ribociclib, Palbociclib) to find the best dose and assess safety/effectiveness against metastatic breast cancer. It's an open-label trial where everyone knows what treatment they're getting.
What are the potential side effects?
Potential side effects include digestive issues, fatigue, blood disorders, liver problems, increased risk of infections and possibly others related to individual drug profiles which will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Estimation of PFS rate at 6 months
Number of DLTs observed during the first cycle
Secondary study objectives
Clinical Benefit Rate
Duration of Response
Overall Response Rate
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Phase 1b Arm E:Experimental Treatment2 Interventions
Elacestrant Dihydrochloride 300 mg, 400 mg + Capivasertib 200 mg, 320 mg, 400 mg
Group II: Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i)Experimental Treatment4 Interventions
Elacestrant Dihydrochloride 300 mg or 400 mg + Palbociclib 100 mg,125 mg OR The recommended Phase 2 dose 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
Group III: Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:Experimental Treatment3 Interventions
Elacestrant Dihydrochloride 100 mg, 200 mg, 300 mg + Ribociclib 400 mg or possibly 600 mg
The recommended Phase 2 dose for the combination of elacestrant and abemaciclib is evaluated in the ongoing ELECTRA trial (ClinicalTrials.gov Identifier: NCT04791384)
Group IV: Phase 1b Arm B: elacestrant with everolimusExperimental Treatment2 Interventions
Elacestrant Dihydrochloride 300 mg or 400 mg + Everolimus 5.0 mg, 7.5 mg or possibly 10 mg
Group V: Phase 1b Arm A: elacestrant with alpelisibExperimental Treatment2 Interventions
Elacestrant Dihydrochloride 300 mg or 400 mg + Alpelisib 250 mg or 300 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1890
Capivasertib
2021
Completed Phase 1
~130
Elacestrant
2019
Completed Phase 3
~560
Alpelisib
2018
Completed Phase 3
~960
Everolimus
2010
Completed Phase 4
~1510
Ribociclib
2018
Completed Phase 3
~2420
Palbociclib
2017
Completed Phase 3
~3790
Find a Location
Who is running the clinical trial?
Stemline Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
6,107 Total Patients Enrolled
2 Trials studying Breast Cancer
4,698 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a PIK3CA mutation.I do not have any severe ongoing infections.I have been treated with everolimus before.I have taken drugs that affect cancer cell resistance within the last 14 days or less.I cannot take pills due to ongoing stomach or bowel issues.I have not taken ribociclib for advanced cancer or within 12 months after adjuvant therapy if my cancer returned.I have jawbone damage from previous treatments with specific bone medications.I have taken abemaciclib for advanced cancer but didn't relapse in the last year.I am fully active or can carry out light work.I am taking or have taken specific medications before starting the trial therapy.My blood tests show my organs and bone marrow are working well.I have not had major surgery in the last 28 days.I am at risk of or have a long QT interval.I haven't had cancer, except for certain skin, bladder, or cervical cancers, in the last 3 years.I have type 1 diabetes or my type 2 diabetes is not under control.I am 18 years or older and understand the consent I am giving.My cancer has spread significantly and is causing severe symptoms.I am not pregnant or breastfeeding and agree to use effective birth control during and after the study.My breast cancer is ER positive and HER2 negative, confirmed by tests.I am premenopausal or perimenopausal and have been on LHRH treatment for at least 4 weeks.I have at least one tumor that can be measured and has not been treated with radiation.I have received chemotherapy or elacestrant for advanced cancer.I have new or active brain metastases.I have previously been treated with a PI3K inhibitor.I have not used experimental hormone therapies for my cancer, except for fulvestrant.I've had 1 or 2 hormone treatments for advanced cancer, including one with a CDK4/6 inhibitor.I have checked the drug guide for any issues with my current medications.I have a BRCA mutation and haven't been treated with PARP inhibitors.I am postmenopausal based on my age, lack of periods, hormone levels, or surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b Arm E:
- Group 2: Phase 1b Arm A: elacestrant with alpelisib
- Group 3: Phase 1b Arm B: elacestrant with everolimus
- Group 4: Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:
- Group 5: Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i)
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.