Study Summary
This trial tests multiple drug combos to find the safest & most effective for treating ER+/HER2- advanced/metastatic breast cancer.
Eligible Conditions
- Breast Cancer
- Metastatic Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 36 months
18 months
Determine the recommended Phase 2 dose (RP2D) of elacestrant in combination with each of the other study drugs
24 months
Characterize the safety of elacestrant in combination with each of the other study drugs
36 months
Clinical Benefit Rate
Duration of Response
Overall Response Rate
Overall Survival
Pharmacokinetic assessment profile of elacestrant and each of the combination drugs.
Progression-free survival
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Phase 1b Arm A: elacestrant with alpelisib
1 of 4
Phase 1b Arm B: elacestrant with everolimus
1 of 4
Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:
1 of 4
Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib ...
1 of 4
Experimental Treatment
322 Total Participants · 4 Treatment Groups
Primary Treatment: Phase 1b Arm A: elacestrant with alpelisib · No Placebo Group · Phase 1 & 2
Phase 1b Arm A: elacestrant with alpelisibExperimental Group · 2 Interventions: Alpelisib, Elacestrant · Intervention Types: Drug, Drug
Phase 1b Arm B: elacestrant with everolimusExperimental Group · 2 Interventions: Everolimus, Elacestrant · Intervention Types: Drug, Drug
Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:Experimental Group · 2 Interventions: Ribociclib, Elacestrant · Intervention Types: Drug, Drug
Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i)Experimental Group · 3 Interventions: Ribociclib, Elacestrant, Palbociclib · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
2015
Completed Phase 1
~30
Everolimus
2010
Completed Phase 4
~1500
Ribociclib
2018
Completed Phase 3
~9090
Elacestrant
2015
Completed Phase 1
~80
Palbociclib
2017
Completed Phase 3
~4170
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
Who is running the clinical trial?
Stemline Therapeutics, Inc.Lead Sponsor
16 Previous Clinical Trials
1,398 Total Patients Enrolled
1 Trials studying Breast Cancer
466 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have agreed to participate in the study by signing a document that explains the study details.
You are a man or woman who is 18 years or older (or the minimum age required by law) and have given consent to participate in the study. Women who are postmenopausal, premenopausal, or perimenopausal can participate.
You are 60 years old or older.
You are a woman under 60 years old who has not had a menstrual period for at least 12 months, or your hormone levels indicate that you are in menopause. If you have received certain medications or treatments, you may not meet this criterion.
You have had a surgery to permanently prevent pregnancy, such as tubal ligation or hysterectomy, at least one month before starting the trial.
You have breast cancer that is confirmed by a lab test and does not have a specific protein called HER2. In addition, the cancer cells have a certain amount of a hormone receptor called ER, as determined by a lab test using specific guidelines.
If you are a woman who has not yet gone through menopause, or a man, you must have started taking a certain type of medication at least 4 weeks before the study begins and plan to continue taking it during the study.
Women who are not able to have children because they are almost done with menopause must have a certain level of FSH hormone in their blood.
You have a visible tumor or bone lesion that can be measured by a specific standard. If you have brain metastases, they must be stable for at least 4 weeks and you must not be taking more than a certain amount of corticosteroids.
You are able to perform daily activities without difficulty or with minimal limitations.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer