Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early 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

Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Pacjent wyraża pisemną zgodę na udział w badaniu.
  • •Zdiagnozowano raka piersi (nie leczono wcześniej), potwierdzonego biopsją.
  • •Zmiana nowotworowa w piersi jest wystarczająco duża, by ją zmierzyć.
  • •Rak piersi jest w początkowym stadium rozwoju (od cT1b do cT3), bez względu na zajęcie węzłów chłonnych.
  • •Rak piersi jest pozytywny na białka HER2 i HR (estrogenowe/progesteronowe), a w komórkach guza stwierdzono mutację PIK3CA.
  • •Pacjent ma ukończone 18 lat.
  • •Ogólny stan zdrowia pacjenta pozwala na udział w badaniu (ECOG 0-1).
  • •Serce pacjenta pracuje prawidłowo (potwierdzone EKG i USG serca).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 11, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (62)

KEM Kliniken Essen-Mitte

Essen, Germany

Hämatologie-Onkologie im Zentrum MVZ GmbH

Augsburg, Germany

DBZ Onkologie

Berlin, Germany

Praxisklinik Krebsheilkunde für Frauen

Berlin, Germany

Klinik für Gynäkologie und Geburtshilfe, Brustzentrum/Studiensekretariat

Berlin, Germany

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Department of Breast-Center Holweide - Kliniken der Stadt Köln

Cologne, Germany

Städtisches Klinikum Dessau

Dessau, Germany

University Hospital Carl Gustav Carus

Dresden, Germany

Gemeinschaftspraxis Haematologie Onkologie

Dresden, Germany

Center for Gynecologic Oncology

Düsseldorf, Germany

Studienzentrale fuer das MVZ Eggenfelden e.K.

Eggenfelden, Germany

Frauenklinik des Universitätsklinikums Erlangen

Erlangen, Germany

Universitätsklinikum Essen

Essen, Germany

Klinik für Gynäkologie und Geburtshilfe Agaplesion Markus Krankenhaus

Frankfurt, Germany

SRH Wald-Klinikum Gera GmbH

Gera, Germany

Mammazentrum HH am Krankenhaus Jerusalem

Hamburg, Germany

Klinikum Hanau

Hanau, Germany

DIAKOVERE Henriettenstift Frauenklinik

Hanover, Germany

National Center for Tumor Diseases - University Hospital Heidelberg

Heidelberg, Germany

Elisabeth Krankenhaus Brustzentrum

Kassel, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Praxis für Hämatologie und Onkologie Koblenz and InVo - Institut für Versorgungsforschung in der Onkologie GbR

Koblenz, Germany

University Hospital Mannheim

Mannheim, Germany

University Hospital Gießen and Marburg, Campus Marburg

Marburg, Germany

Media Vita GmbH (MVZ)

Münster, Germany

St. Louise Frauen- und Kinderklinik

Paderborn, Germany

University Hospital Tübingen

Tübingen, Germany

Department of Gynecology and Obstetrics - University of Ulm

Ulm, Germany

GRN Klinik Weinheim

Weinheim, Germany

Klinikum Worms

Worms, Germany

Helios Universitätsklinikum Wuppertal

Wuppertal, Germany

AOSS Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Università Politecnica delle Marche - Azienda Ospedaliero Universitarià delle Marche

Ancona, Italy

Uo Medicina Oncologica Ospedale Di Carpi

Carpi, Italy

ASST Lecco Ospendale A. Manzoni

Lecco, Italy

AULSS9 Scaligera - Ospedale Mater Salutis di Legnago

Legnago, Italy

Istituto Europeo di Oncologica

Milan, Italy

Instituti Clinici Scientifici Maugeri S.p.A. SB Oncologia Medica

Pavia, Italy

SOC Oncologia S. Maria della Misericordia

Udine, Italy

Ospedale di Circolo e Fondazione Macchi

Varese, Italy

Narodowy Instytut Onkologii

Warsaw, Poland

Spitalul Clinic Filantropia

Bucharest, Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuta"

Cluj-Napoca, Romania

Institutul Regional de Oncologie Iasi

Iași, Romania

Centrul ONCOMED SRI

Timișoara, Romania

Narodny onkologicky ustav

Bratislava, Slovakia

Hospital Clinic of Barcelona Medical Oncology

Barcelona, Spain

Hospital Universitari Vall d´Hebron

Barcelona, Spain

Institut Catalá dÒncologia (ICO)

Barcelona, Spain

Hospital Universitario Clinico San Cecilio Oncology

Granada, Spain

Fundació IRB Lleida Oncología, Unidad de ensayos clínicos

Lleida, Spain

Hospital de Madrid Notre Sanchinarro (CIOCC)

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Ramon y Cajal Servicio de Oncología Médica/ Oficina de Ensayos Clínicos

Madrid, Spain

Hospital General Universitario Morales Meseguer

Murcia, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Hospital Universitario Marquès de Valdecilla Servicio de Oncologia Medica

Santander, Spain

Hospital Universitario Virgen der Rocio

Seville, Spain

Fundación Instituto Valenciano de Oncología (IVO)

Valencia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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