Condition: Hormone Receptor Positive HER-2 Negative Breast Cancer · Advanced or Metastatic Breast Cancer · BRCA1 Mutation · Sponsor: GBG Forschungs GmbH
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 for standard-of-care PARP inhibitor therapy and planned treatment with olaparib, an ECOG performance status of 0-2 and life expectancy of \> 6 months, with normal bone marrow and kidney functions and no active or newly diagnosed central nervous system (CNS) metastases or symptomatic metastatic visceral disease at risk of life-threatening complications. Interventions: Patients randomized to Arm A will receive 600 mg olaparib daily and 400 mg elacestrant daily, while patients randomized to Arm B will receive 600 mg olaparib daily. Blood tests (hematology, biochemistry) will be performed at the beginning of every cycle, and imaging for tumor assessment (chest and abdominopelvic imaging) as well as QoL assessments will be performed every three months and in case of suspicion of progression/end of study.
This description comes directly from the study's public registry record.
Laura Steinmann · +49 61027480 · element@gbg.de
Stefan Schoeffel · +49 61027480 · element@gbg.de
Always discuss trial participation with your own doctor first.
| Vinzenz Von Paul Kliniken gGmbH - Marienhospital | Stuttgart, Baden-Wurttemberg, Germany | Recruiting |
| University Hospital Tübingen | Tübingen, Baden-Wurttemberg, Germany | Recruiting |
| Rems-Murr-Klinik-Winnenden | Winnenden, Baden-Wurttemberg, Germany | Recruiting |
| GRN Klinik Weinheim | Weinheim, Baden-Württembergs, Germany | Recruiting |
| Hämatologie-Onkologie im Zentrum MVZ GmbH | Augsburg, Bavaria, Germany | Recruiting |
| Klinikum Bayreuth | Bayreuth, Bavaria, Germany | Recruiting |
| Schwerpunktpraxis der Gynäkologie und Onkologie | Fürstenwalde, Brandenburg, Germany | Recruiting |
| Agaplesion Frankfurter Diakonie Kliniken gGmbH | Frankfurt am Main, Hesse, Germany | Recruiting |
| Klinikum der J. W. Goethe Universität | Frankfurt am Main, Hesse, Germany | Recruiting |
| Klinikum Kassel GmbH - Frauenklinik | Kassel, Hesse, Germany | Recruiting |
| St. Josefs-Hospital, Gynäkologie und Geburtshilfe | Wiesbaden, Hesse, Germany | Recruiting |
| Studien GbR Braunschweig | Braunschweig, Lower Saxony, Germany | Recruiting |
+ 24 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06201234