NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Trastuzumab-deruxtecan Versus Pacli-/Docetaxel+Carboplatin+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer

Status: Active_not_recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC. ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC. Moreover, it aims to demonstrate excellent survival in patients treated by T-DXd (with the use of standard chemotherapy at investigator´s decision restricted only to patients with substantial residual tumour burden after T-DXd-treatment).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Patients eligible for inclusion in this study must meet all the following criteria:

• Female patients with invasive, untreated HER2+ breast cancer (as assessed by local pathology) maximum 6 weeks before registration (standard-of-care diagnostic biopsy according to current AGO guidelines)

• Age ≥18 years 3a. Cohort 1: low- to intermediate-risk for recurrence as per investigator´s decision (recommendation: cT1c - cT2 (1 - ≤3cm), cN0; cT1a/b excluded), OR 3b. Cohort 2: intermediate- to high-risk for recurrence as per investigator´s decision (recommendation: cT2 (\>3 - ≤5cm), cN0) 3c. Elderly patients (≥ 65 years) may be assigned to any cohort as per investigator's decision

⁃ 4\. Written informed consent 5. LVEF ≥ 50% within 28 days before randomisation 6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 7. Adequate organ and bone marrow function within 14 days before randomisation 8. Adequate treatment washout period before randomisation (refer to protocol for detailed information) 9. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential (refer to protocol for detailed information) 10. Female subjects must not donate, or retrieve for their own use, ova from the time of randomisation and throughout the study treatment period, and for at least 7 months after the final study drug administration. (refer to protocol for detailed information)

Locations
Other Locations
Germany
Uniklinik RWTH Aachen
Aachen
Hämotologisch onkologische Praxis Heinrich Bangerter Augsburg GbR
Augsburg
Universitätsklinikum Augsburg / Klinik für Frauenheilkunde und Geburtshilfe
Augsburg
Klinikum Mittelbaden, Brustzentrum
Baden-baden
Charite Campus Mitte
Berlin
Ev. Waldkrankenhaus Spandau
Berlin
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld
Studien GbR Braunschweig
Braunschweig
Klinikum Bremerhaven Reinkenheide
Bremerhaven
Kliniken der Stadt Köln GmbH / Brustzentrum Holweide
Cologne
St. Elisabeth Krankenhaus GmbH
Cologne
Kliniken für Frauenheilkunde / Universitätsklinikum Düsseldorf
Düsseldorf
Luisenkrankenhaus GmbH
Düsseldorf
Sankt-Antonius-Hospital
Eschweiler
Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum
Essen
Universitätsklinikum Essen, Brustzentrum
Essen
AGAPLESION Markus Krankenhaus Gynäkologie
Frankfurt Am Main
Klinikum Frankfurt Höchst GmbH
Frankfurt Am Main
Praxis für Interdisziplinäre Onkologie und Hämatologie (PIO)
Freiburg Im Breisgau
Niels-Stensen-Kliniken Franziskus-Hospital
Georgsmarienhütte
Onkodok Gütersloh
Gütersloh
Brustzentrum am Krankenhaus Jerusalem
Hamburg
Universitätsklinikum Hamburg-Eppendorf / Klinik und Poliklinik für Gynäkologie
Hamburg
St. Barbara Klinik
Hamm
Ärztehaus am Bahnhofsplatz
Hildesheim
Klinikum Kassel
Kassel
Universitätsklinikum Leipzig
Leipzig
UK Schleswig Holstein
Lübeck
Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus
Mönchengladbach
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik
Munich
Rotkreuz Klinikum München
Munich
MVZ Media Vita am St. Franziskus Hospital
Münster
Frauenklinik St. Louise-St. Vincenz-KH GmbH
Paderborn
Frauenklinik / Brustzentrum am Klinikum Obergölzsch Rodewisch
Rodewisch
Universittsklinikum am Klinikum Südstadt
Rostock
CaritasKlinikum Saarbrücken St. Theresia
Saarbrücken
MKS St. Paulus GmbH
Schwerte
MVZ Klinik Dr. Hancken GmbH
Stade
Klinikum Mutterhaus
Trier
Praxisnetzwerk Hämatologie und intern. Onkologie
Troisdorf
Universitätsklinikum Tübingen
Tübingen
Universitätsklinikum Ulm
Ulm
Helios-Klinik Wuppertal
Wuppertal
Time Frame
Start Date: 2024-02-05
Completion Date: 2029-06
Participants
Target number of participants: 402
Treatments
Experimental: T-DXd: HER2+ and low-intermediate risk for recurrence
12 weeks T-DXd i.v. in neoadjuvant treatment; pCR dependent T-DXd for 1 year in total in postneoadjuvant treatment
Experimental: T-DXd: HER2+ and intermediate-high risk for recurrence
18 weeks T-DXd i.v. in neoadjuvant treatment; pCR dependent T-DXd for 1 year in total in postneoadjuvant treatment
Other: Control: HER2+ and low-intermediate risk for recurrence
Standard-of-Care-Treatment: 12 weeks PAC+T+P (standard-of-care) in neoadjuvant treatment; pCR dependent SOC chemotherapy +T+/-P or SOC T+/-P for 1 year in total in postneoadjuvant treatment
Other: Control: HER2+ and intermediate-high risk for recurrence
Standard-of-Care-Treatment: 18 weeks PAC/DOC+Carbo+T+P (standard-of-care) in neoadjuvant treatment; pCR dependent SOC chemotherapy +T+/-P or SOC T+/-P for 1 year in total in postneoadjuvant treatment
Related Therapeutic Areas
Sponsors
Collaborators: AstraZeneca
Leads: West German Study Group

This content was sourced from clinicaltrials.gov