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TPS598 : ADAPTlate: A randomized, controlled, open-label, phase III trial on adjuvant dynamic marker—Adjusted personalized therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) high-risk, HR+/HER2- early breast cancer.

Researchers

Presenter

  • Oleg Gluz

Principal Investigators

  • Iris Scheffen

  • Tom Degenhardt

  • Norbert Walter Marschner

  • Matthias Christgen

  • Hans Heinrich Kreipe

  • Ulrike Nitz

  • Ronald E. Kates

  • Timo Schinkoethe

  • Monika Karla Graeser

  • Rachel Wuerstlein

  • Sherko Kuemmel

  • Lelia Bauer

  • Christian Schem

  • Tanja N. Fehm

  • Hans Neubauer

  • Nadia Harbeck

Medical Centers

  • West German Study Group and Ev. Hospital Bethesda, Breast Center Niederrhein, Moenchengladbach, Germany and University Hospital Cologne, Cologne, Germany

  • Westdeutsche Studiengruppe GmbH, Evangelical Hospital Bethesda, Mönchengladbach, Germany

  • Breast Center, Dept. LMU-Clinics and CCCLMU, Munich, Germany

  • Joint Practice for Interdisciplinary Oncology and Hematology, Freiburg, Germany

  • Medical School Hannover, Institute of Pathology, Hannover, Germany

  • West German Study Group/ Breast Center Niederrhein, Moenchengladbach, Germany

  • West German Study Group, Moenchengladbach, Germany

  • CANKADO Service GmbH, Munich, Germany

  • West German Study Group and Ev. Hospital Bethesda, Breast Center Niederrhein, Moenchengladbach, Germany and Department of Gynecology, University Medical Center Hamburg, Hamburg, Germany

  • Breast Center, Dept. OB&GYN, University of Munich (LMU) and CCCLMU, Munich, Germany

  • Breast Center, Ev. Clinics Essen-Mitte and West German Study Group, Essen, Germany

  • GRN Clinics, Breast Center, Weinheim, Germany

  • Mammazentrum Hamburg Brustklinik am Krankenhaus Jerusalem, Hamburg, Germany

  • Department of Obstetrics and Gynaecology, University Hospital Duesseldorf, Duesseldorf, Germany

  • University of Duesseldorf, Dept. Gynecology & Obstetrics, Scientific Laboratories, Duesseldorf, Germany

  • Breast Center, Dept. Obstetrics & Gynecology, University of Munich (LMU) and CCCLMU and West German Study...

Locations

  • Germany

Companies

  • CANKADO Service GmbH

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Breast cancer

Biomarkers

  • Circulating tumor cells

  • Cyclin-dependent kinase 4

  • erb-b2 receptor tyrosine kinase 2

  • Transthyretin

  • Circulating DNA

Drug/Treatment

  • Abemaciclib

Outcome

  • N/A


Study Design

  • Randomized

  • Open Label

  • Superiority

  • Multiple Arm

  • Multicenteric

  • Prospective

  • Controlled

Phase

  • III

Study Id's

  • NCT04565054

Sponsors

  • N/A

Result

  • N/A