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

NCT05563220 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 435

Last updated 2026-01-06

No results posted yet for this study

Summary

This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.

Conditions

Interventions

DRUG

Elacestrant

Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days

DRUG

Alpelisib

Alpelisib 150 mg or 250 mg once daily in cycles of 28 days

DRUG

Everolimus

Everolimus 5 mg, 7.5 mg, or 10 mg once daily in cycles of 28 days

DRUG

Ribociclib

Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days

DRUG

Palbociclib

Palbociclib 100 mg or 125 mg once daily for 21 days followed by 7 days off in cycles of 28 days

DRUG

Capivasertib

Capivasertib 200 mg or 320 mg or 400 mg twice daily for 4 days on, 3 days off in cycles of 28 days

DRUG

Abemaciclib

Abemaciclib 100 mg or 150 mg twice daily in cycles of 28 consecutive days

Sponsors & Collaborators

  • Stemline Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-24
Primary Completion
2026-12-27
Completion
2028-12-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Luxembourg
  • Poland
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05563220 on ClinicalTrials.gov