← Back to Search

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

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 more

Awards & 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