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

PHASE2RecruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

January 2, 2023

Primary Completion Date

October 31, 2026

Study Completion Date

January 31, 2027

Conditions
HER2-positive Breast Cancer
Interventions
DRUG

Inavolisib

daily application of 9 mg (may be decreased to 6 mg and to 3 mg)

DRUG

PHESGO

fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase s.c. (PH-FDC SC) q3w beginning on day 1 of cycle 1 for 6 cycles (18 weeks)

DRUG

Endocrine therapy

Endocrine therapy per physician´s choice with either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue for premenopausal women and men

Trial Locations (29)

12623

NOT_YET_RECRUITING

DBZ Onkologie, Berlin

13597

RECRUITING

Praxisklinik Krebsheilkunde für Frauen, Berlin

20141

RECRUITING

Istituto Europeo di Oncologica, Milan

20357

RECRUITING

Mammazentrum HH am Krankenhaus Jerusalem, Hamburg

30171

NOT_YET_RECRUITING

DIAKOVERE Henriettenstift Frauenklinik, Hanover

33604

RECRUITING

Onkologische Schwerpunktpraxis Bielefeld, Bielefeld

34117

RECRUITING

Elisabeth Krankenhaus Brustzentrum, Kassel

35043

NOT_YET_RECRUITING

University Hospital Gießen and Marburg, Campus Marburg, Marburg

37045

NOT_YET_RECRUITING

AULSS9 Scaligera - Ospedale Mater Salutis di Legnago, Legnago

40235

RECRUITING

Center for Gynecologic Oncology, Düsseldorf

42283

RECRUITING

Helios Universitätsklinikum Wuppertal, Wuppertal

45136

RECRUITING

KEM Kliniken Essen-Mitte, Essen

48145

NOT_YET_RECRUITING

Media Vita GmbH (MVZ), Münster

51067

RECRUITING

Department of Breast-Center Holweide - Kliniken der Stadt Köln, Cologne

56068

RECRUITING

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

60431

RECRUITING

Klinik für Gynäkologie und Geburtshilfe Agaplesion Markus Krankenhaus, Frankfurt

63450

NOT_YET_RECRUITING

Klinikum Hanau, Hanau

67550

NOT_YET_RECRUITING

Klinikum Worms, Worms

68167

NOT_YET_RECRUITING

University Hospital Mannheim, Mannheim

69120

RECRUITING

National Center for Tumor Diseases - University Hospital Heidelberg, Heidelberg

69469

NOT_YET_RECRUITING

GRN Klinik Weinheim, Weinheim

72076

RECRUITING

University Hospital Tübingen, Tübingen

86150

RECRUITING

Hämatologie-Onkologie im Zentrum MVZ GmbH, Augsburg

89075

NOT_YET_RECRUITING

Department of Gynecology and Obstetrics - University of Ulm, Ulm

91054

NOT_YET_RECRUITING

Frauenklinik des Universitätsklinikums Erlangen, Erlangen

06847

NOT_YET_RECRUITING

Städtisches Klinikum Dessau, Dessau

01307

RECRUITING

University Hospital Carl Gustav Carus, Dresden

07548

RECRUITING

SRH Wald-Klinikum Gera GmbH, Gera

Unknown

NOT_YET_RECRUITING

Università Politecnica delle Marche - Azienda Ospedaliero Universitarià delle Marche, Ancona

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

GBG Forschungs GmbH

OTHER