Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer

Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1 randomization into Arm A (olaparib + elacestrant) or arm B (olaparib). Treatment in either arm will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study. Trial population: Patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with an indication

Trial Details

NCT ID
NCT06201234
Phase
PHASE2
Sponsor
GBG Forschungs GmbH
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Olaparib + Elacestrant
  • Olaparib
Locations (sample)
  • Stuttgart, Baden-Wurttemberg, Germany|48.78232,9.17702
  • Tübingen, Baden-Wurttemberg, Germany|48.52266,9.05222
  • Winnenden, Baden-Wurttemberg, Germany|48.87563,9.39819
  • Weinheim, Baden-Württembergs, Germany|49.54887,8.66697
  • Augsburg, Bavaria, Germany|48.37154,10.89851

Key Eligibility Criteria

  • Patients will be eligible for study participation only if they comply with the following criteria:
  • Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for scheduled visit, the t…
  • Female or male patients.
  • Age at study entry of at least 18 years.

For full eligibility, visit ClinicalTrials.gov.

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