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

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.

Trial Details

NCT ID
NCT05563220
Phase
PHASE1 / PHASE2
Sponsor
Stemline Therapeutics, Inc.
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Elacestrant
  • Alpelisib
  • Everolimus
  • Ribociclib
  • Palbociclib
  • Capivasertib
Locations (sample)
  • Dothan, Alabama, United States|31.22323,-85.39049
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • Arcadia, California, United States|34.13973,-118.03534
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Participant has signed the informed consent before all study specific activities are conducted.
  • Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female par…
  • Postmenopausal status is defined as follows or in accordance with local regulations:
  • Age ≥60 years or

For full eligibility, visit ClinicalTrials.gov.

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