Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT05563220
Trial Phases:	Phase I Phase II	Protocol IDs:	STML-ELA-0222 (primary) NCI-2023-02463
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Stemline Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05563220

Summary

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.

Objectives

This is a multicenter, Phase 1b/2 trial. The Phase 1b aims at selecting the RP2D dose,
defined as a dose that is associated with less than 33% of patients experiencing a DLT of
elacestrant when administered in combination with alpelisib, everolimus, palbociclib,
abemaciclib, and ribociclib, that is, â?¤1 patient experiencing a DLT out of 6 DLT
evaluable patients. For each combination, this phase will have between 1 and 3 cohorts of
6 DLT-evaluable patients each. The total number of DLT-evaluable patients in all the
combinations will vary between 24 and 72.

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.

The treatment arms will be:

- Arm A: 50 patients: elacestrant with alpelisib;

- Arm B: 50 patients: elacestrant with everolimus;

- Arm C: 60 patients (30 patients in each combination): elacestrant with either
abemaciclib or ribociclib;

- Arm D: 90 patients (30 patients in each combination): elacestrant with either
palbociclib, abemaciclib, or ribociclib

- Arm E: 60 patients: elacestrant with capivasertib

Phase 1b will have a total of 90 patients, while Phase 2 will have 310 patients for all
treatment arm combinations.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.