RecruitingPhase 2NCT05306041

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

A Randomized, Open-label, Phase II Trial Comparing Neoadjuvant Endocrine Therapy in Combination with Trastuzumab, Pertuzumab +/- the PI3K Inhibitor Inavolisib in Patients with HER2-positive, HR-positive, PIK3CA Mutant Early Breast Cancer-GeparPiPPa

Sponsor

GBG Forschungs GmbH

Enrollment

170 participants

Start Date

Jan 2, 2023

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding inavolisib (a PI3K inhibitor drug that blocks a cancer growth pathway) to standard pre-surgery hormone therapy (endocrine therapy) can shrink HER2-positive, hormone receptor-positive, PIK3CA-mutant breast cancer more effectively before surgery. **You may be eligible if...** - You have untreated, early-stage HER2-positive and hormone receptor-positive breast cancer confirmed by biopsy - Your tumor has a PIK3CA mutation (a specific gene change that makes tumors more likely to respond to this drug) - Your tumor is measurable on ultrasound and you are not yet post-surgical - Your disease is at stage cT1b–cT3 **You may NOT be eligible if...** - You have already started treatment for this breast cancer - Your tumor is HER2-negative or hormone receptor-negative - You do not have a confirmed PIK3CA mutation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInavolisib

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

DRUGPHESGO

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)

DRUGEndocrine therapy

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

Locations(29)

KEM Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Hämatologie-Onkologie im Zentrum MVZ GmbH

Augsburg, Germany

DBZ Onkologie

Berlin, Germany

Praxisklinik Krebsheilkunde für Frauen

Berlin, Germany

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, Germany

Department of Breast-Center Holweide - Kliniken der Stadt Köln

Cologne, Germany

Städtisches Klinikum Dessau

Dessau, Germany

University Hospital Carl Gustav Carus

Dresden, Germany

Center for Gynecologic Oncology

Düsseldorf, Germany

Frauenklinik des Universitätsklinikums Erlangen

Erlangen, 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

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

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

Università Politecnica delle Marche - Azienda Ospedaliero Universitarià delle Marche

Ancona, Italy

AULSS9 Scaligera - Ospedale Mater Salutis di Legnago

Legnago, Italy

Istituto Europeo di Oncologica

Milan, Italy

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NCT05306041

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