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Stemline Trials 1-877-332-7961
clinicaltrials@menarinistemline.com


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Be Part of Research - Trial Details - Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
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Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

Recruiting

Open to: ALL

Age: 18.0 - N/A

Liverpool London Liverpool London London

Medical Conditions

Breast Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jan 2023 Dec 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days

Intervention Arm Group : 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);Phase 1b Arm E:;

Intervention Type : DRUG
Intervention Description : Alpelisib 250 mg or 300 mg once daily in cycles of 28 days

Intervention Arm Group : Phase 1b Arm A: elacestrant with alpelisib;

Intervention Type : DRUG
Intervention Description : Everolimus 5 mg, 7.5 mg, or 10 mg once daily in cycles of 28 days

Intervention Arm Group : Phase 1b Arm B: elacestrant with everolimus;

Intervention Type : DRUG
Intervention Description : Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days

Intervention Arm Group : Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:;Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i);

Intervention Type : DRUG
Intervention Description : Palbociclib 100 mg or 125 mg once daily for 21 days followed by 7 days off in cycles of 28 days

Intervention Arm Group : Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i);

Intervention Type : DRUG
Intervention Description : Capivasertib 200 mg or 320 mg or 400 mg twice daily for 4 days on, 3 days off in cycles of 28 days

Intervention Arm Group : Phase 1b Arm E:;

Intervention Type : DRUG
Intervention Description : Abemaciclib 100 mg or 150 mg twice daily in cycles of 28 consecutive days

Intervention Arm Group : Phase 1b Arm C: elacestrant with abemaciclib or ribociclib:;Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Clatterbridge Cancer Centre NHS Foundation Trust
    Liverpool
    L7 8YA
  • North Middlesex University Hospital
    London
    N18 1QX
  • Liverpool Hospital
    Liverpool
    NSW 2170
  • Sarah Cannon Research Institute UK; Ltd
    London
    W1G 6AD
  • University College London Hospitals NHS Foundation Trust; The London Clinic - Main Hospital
    London
    W1T 7HA

Stemline Trials 1-877-332-7961
clinicaltrials@menarinistemline.com



The study is sponsored by Stemline Therapeutics, Inc.




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Read full details for Trial ID: NCT05563220
Last updated 30 April 2025

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