Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pisemna zgoda na udział w badaniu przed jego rozpoczęciem
- •Kobieta lub mężczyzna
- •Wiek co najmniej 18 lat
- •Zaawansowany lub rozsiany rak piersi dodatni na receptor hormonalny (HR+) i ujemny na HER2
- •Mutacja w genach BRCA1 lub BRCA2
- •Gotowość do udostępnienia próbki tkanki guza z archiwum
- •Zaplanowane leczenie inhibitorem PARP (olaparib)
- •Ogólny stan zdrowia pozwalający na участие w badaniu (ECOG 0-2)
✗ Disqualifies
- •Uczulenie na któryś ze składników leku
- •Nowe lub aktywne przerzuty w mózgu, z wyjątkiem stabilnych przerzutów po zakończonej radioterapii
- •Rozległy rozsiany rak z zagrażającymi życiu powikłaniami, takie jak masywny wyciek płynu do jamy brzusznej, opłucnej lub osierdzia
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- December 1, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (36)
Vinzenz Von Paul Kliniken gGmbH - Marienhospital
Stuttgart, Germany
University Hospital Tübingen
Tübingen, Germany
Rems-Murr-Klinik-Winnenden
Winnenden, Germany
GRN Klinik Weinheim
Weinheim, Germany
Hämatologie-Onkologie im Zentrum MVZ GmbH
Augsburg, Germany
Klinikum Bayreuth
Bayreuth, Germany
Schwerpunktpraxis der Gynäkologie und Onkologie
Fürstenwalde, Germany
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Frankfurt am Main, Germany
Klinikum der J. W. Goethe Universität
Frankfurt am Main, Germany
Klinikum Kassel GmbH - Frauenklinik
Kassel, Germany
St. Josefs-Hospital, Gynäkologie und Geburtshilfe
Wiesbaden, Germany
Studien GbR Braunschweig
Braunschweig, Germany
MVZ Onkologische Kooperation Harz GbR
Goslar, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinik Köln
Cologne, Germany
Heinrich-Heine-Universität Düsseldorf
Düsseldorf, Germany
Zentrum für Gynäkologische Onkologie am MVZ Medical Center Düsseldorf GmbH
Düsseldorf, Germany
KEM Kliniken Essen-Mitte GmbH
Essen, Germany
Marienhospital Witten
Witten, Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany
Institut für Versorgungsforschung Mayen
Mayen, Germany
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Saarbrücken, Germany
University Hospital Carl Gustav Carus
Dresden, Germany
Gemeinschaftspraxis Dr.Illmer, Dr. Wolf, Dr. Jacobasch, Dr. Freiberg-Richter
Dresden, Germany
Universität Leipzig
Leipzig, Germany
MediOnko-Institut GbR
Berlin, Germany
Das Brust Zentrum - Die Frauenärzte
Berlin, Germany
Marienhospital Bottrop gGmbH
Bottrop, Germany
Universitätsklinikum Essen - Klinik für Frauenheilkunde und Geburtshilfe
Essen, Germany
National Center for Tumor Diseases Heidelberg
Heidelberg, Germany
Universitätsklinikum des Saarlandes - Frauenklinik
Homburg, Germany
Rotkreuzklinikum München
München, Germany
Studienzentrum Onkologie Ravensburg
Ravensburg, Germany
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Stuttgart, Germany
Klinikum Worms
Worms, Germany
Trial contact
Laura Steinmann
Stefan Schoeffel
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.