Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer

PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+/HER2-negative breast cancer with aiming at evaluating the biological effects of elacestrant with or without triptorelin.

Trial Details

NCT ID
NCT05982093
Phase
PHASE2
Sponsor
SOLTI Breast Cancer Research Group
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Elacestrant
  • Triptorelin
  • Tamoxifen 20 mg
Locations (sample)
  • Badalona, Barcelona, Spain|41.45004,2.24741
  • L'Hospitalet de Llobregat, Barcelona, Spain|41.35967,2.10028
  • Vilanova, Lleida, Spain|42.81667,-7.01667
  • El Palmar, Murcia, Spain|37.93939,-1.16095
  • Badajoz, Spain|38.87789,-6.97061

Key Eligibility Criteria

  • Signed informed consent must be obtained prior to any trial-specific procedure.
  • Female patients who are at least 35 years of age on the day of signing informed consent.
  • Patient is premenopausal at the time of study entry
  • Premenopausal status is defined as either:

For full eligibility, visit ClinicalTrials.gov.

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