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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
PIK3CA mutation by local laboratory assessment.
Premenopausal and perimenopausal women (who do not fit postmenopausal criteria) and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist initiated at least 4 weeks before the start of trial therapy and are planning to continue LHRH agonist treatment during the study treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

ELEVATE Trial 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.Check my eligibility
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.See study design
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.

ELEVATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has a PIK3CA mutation.
Select...
I am premenopausal or perimenopausal and have been on LHRH treatment for at least 4 weeks.
Select...
I am fully active or can carry out light work.
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My breast cancer is ER positive and HER2 negative, confirmed by tests.
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I have at least one tumor that can be measured and has not been treated with radiation.

ELEVATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estimation of PFS rate at 6 months
Number of DLTs observed during the first cycle
Secondary outcome measures
Clinical Benefit Rate
Duration of Response
Overall Response Rate
+3 more

ELEVATE 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
~1710
Capivasertib
2021
Completed Phase 1
~130
Elacestrant
2015
Completed Phase 1
~80
Alpelisib
2018
Completed Phase 3
~900
Everolimus
2010
Completed Phase 4
~1510
Ribociclib
2018
Completed Phase 3
~2330
Palbociclib
2017
Completed Phase 3
~3710

Find a Location

Who is running the clinical trial?

Stemline Therapeutics, Inc.Lead Sponsor
18 Previous Clinical Trials
1,485 Total Patients Enrolled
1 Trials studying Breast Cancer
478 Patients Enrolled for Breast Cancer

Media Library

Elacestrant (Selective Estrogen Receptor Degrader (SERD)) Clinical Trial Eligibility Overview. Trial Name: NCT05563220 — Phase 1 & 2
Breast Cancer Research Study Groups: Phase 1b Arm E:, Phase 1b Arm A: elacestrant with alpelisib, Phase 1b Arm B: elacestrant with everolimus, Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:, Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i)
Breast Cancer Clinical Trial 2023: Elacestrant Highlights & Side Effects. Trial Name: NCT05563220 — Phase 1 & 2
Elacestrant (Selective Estrogen Receptor Degrader (SERD)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05563220 — Phase 1 & 2

Frequently Asked Questions

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

Is this research actively seeking volunteers?

"Yes, the information published on clinicaltrials.gov reveals that this investigation is actively recruiting participants. This research was first posted to the website on January 24th 2023 and had its latest update on February 23rd 2023. The study aims to recruit 322 people from 1 site alone."

Answered by AI
~157 spots leftby Dec 2024