Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Aromatase Inhibitors

Abemaciclib 150 mg, 2 x daily, resulting in 300 mg/day, oral, 24 months plus endocrine treatment of physician´s choice

Standard-of-care ET according to clinical guidelines.

Pre-/perimenopausal patients:

* Either aromatase inhibitor + GnRH agonist
* or Tamoxifen +/- GnRH-agonist (as per investigator´s decision) or

Postmenopausal patients:

* Either Aromatase inhibitor
* or Tamoxifen OR

Experimental: Abemaciclib plus ET Abemaciclib 150 mg, 2 x daily, resulting in 300 mg/day, oral, 24 months plus endocrine treatment of physician´s choice

Abemaciclib 50 MG; 150mg 1-0-1 per os

Anja Braschoß, MD

Bettina Bonn, Dr.

Matthias Zaiss, Dr. med.

Norbert Marschner, Dr. med.

Beatrix Janke

Nadine Michel

Thomas Decker, Prof. Dr.

Tobias Dechow, Prof. Dr.

Kristina Veselinovic, Dr. med.

Fabienne Schochter, Dr. med.

Lelia Bauer, Dr. med.

Bettina Müller, Dr. med.

Andreas Hartkopf, Prof.Dr.

Tobias Engler, Dr.

Andreas Hartkopf

Tobias Engler

Bernhard Heinrich, Dr. med.

Markus Bangerter, Prof. Dr.

Christoph Salat, Prof. Dr.

Oliver Stoetzer, PD. Dr.

Dominik Pretscher, Dr. med.

Björn Schöttker, Dr. med.

Nadia Harbeck, Prof. Dr.

Rachel Würstlein

Rachel Würstlein, PD Dr. med.

Michael Braun, Prof.Dr

Claus Alexandra Hanusch, Dr

Michael Braun

Claus Alexandra Hanusch

Nikola Bangemann, Dr. med.

Juliane Bock

Dorothea Fischer, Prof.Dr.

Björn Beurer, Dr.

Dorothea Fischer

Björn Beurer

Antje Lehnert, Dr

Anna-Kathrin Bicker, Dr

Antje Lehnert

Anna-Kathrin Bicker

Hans Tesch, Prof. Dr.

Jochen Breuer, Dr. med.

Andreas Köhler, Dr. med.

Roswitha Fuchs, Dr. med.

Janine Kreiss-Sender, Dr. med.

Ralf Lorenz, Dr. med.

Mark-Oliver Zahn, Dr. med.

Timo Kambach, Dr. med.

Tjoung-Won Park-Simon, Prof. Dr.

Elna Kühnle, Dr. med.

Lothar Müller, Dr. med.

Detlev Schröder, Dr. med.

Frank Griesinger, Prof. Dr.

Anne Lüers, Dr. med.

Toralf Reimer, Prof. Dr.

Christian George, Dr. med.

Kerstin Lüdtke-Heckenkamp, Dr. med.

Jost Christoph Wamhoff, Dr. med.

Kristina Lübbe, Dr. med.

Angela Kentsch, Dr. med.

Mathias Warm, MD

Myriam Vincent

Mathias Warm, Prof. Dr.

Myriam Vincent, Dr. med.

Mahmoud Danaei, Dr

Miriam Kohlschein

Mahmoud Danaei

Katja Krauss, Dr. med.

Elmar Stickeler, Prof. Dr.

Christian Rudlowski, Prof.Dr.

Lena Leitzen

Christian Rudlowski

Marianne Just, Dr. med.

Siemke Steinke, Dr. med.

Christian Martin Kurbacher, PD. Dr.

Jutta Kurbacher

Christian Martin Kurbacher, Prof. Dr.

Katja Ziegler-Löhr, Dr. med.

Solvejg Rellecke, Dr. med.

Tanja Fehm, Prof. Dr.

Eugen Ruckhäberle, Prof. Dr.

Maren Darsow, Dr. med.

Athina Kostara, Dr. med.

Peter Staib, PD. Dr.

Meike Münchow, Dr. med.

Mattea Reinisch, Dr. med.

Sherko Kümmel, Prof. Dr.

Oliver Hoffmann, PD. Dr.

Ann-Kathrin Bittner, PD. Dr.

Reinhard Depenbusch, Dr. med.

Philipp Schütt, PD Dr.

Christoph Uleer, Dr. med.

Jasmin Pourfard, Dr. med.

Gunther Rogmans, Dr. med.

Marina Wirtz, Dr. med.

Julian Puppe, Dr.

Anne-Katrin Oligmüller, Dr.

Julian Puppe

Anne-Katrin Oligmüller

Peter Dall, Prof. Dr.

Eric Boetel, Dr. med.

Peter Dall

Eric Boetel

Martin Griesshammer, Prof. Dr.

Hans-Joachim Tischler, Dr. med.

Oleg Gluz, PD. Dr. med.

Raquel von Schumann

Oleg Gluz, PD Dr. med.

Joke Tio, Dr. med.

Carl Christian Opitz, Dr. med.

Sarah Wetzig

Michael Hartmann, Dr.

Michael Hartmann

Cristin Kühn, Dr. med.

Heidi Wortelmann, Dr. med.

John Hackmann, Dr. med.

Matthias Zeth

Vesna Bjelic-Radisic, Prof. Dr.

Rolf Mahlberg, Dr. med.

Stefan Heidel, Dr. med.

Rudolf Weide, Prof. Dr.

Jörg Thomalla, Dr. med.

Erich-Franz Solomayer, Prof. Dr.

Lisa Stotz, Dr. med.

Stefanie Strobel, Dr.

Barbara Prediger, Dr

Stefanie Strobel

Barbara Prediger

Christoph Thomssen, Prof. Dr.

Susanne Barrot, Dr. med.

Holm Eggemann, Prof. Dr.

Daniela Meiners

Andrea Stefek, Dr. med.

Sylvia Ruth, Dr. med.

Petra Krabisch, Dr. med.

Franziska Stuckert

Thomas Göhler, Dr. med.

Steffen Dörfel, Dipl.-Med.

Gabriele Prange-Krex, Dr. med.

Johannes Mohm, Dr. med.

Uwe Köhler, Prof. Dr.

Catrin Frömter, Dr. med.

Peter Klare, Dr. med.

Gläser, Steffen Gläser, Dr. med.

Lidia Perlova-Griff

Gerd Graffunder, Dr.

Gerd Graffunder

Anke Kleine-Tebbe, Dr.

Kerstin Brandt, Dr.

Anke Kleine-Tebbe

Kerstin Brandt

Ralf Meyer, Dr. med.

Carsten Schreiber, Dr. med.

Mustafa Celalettin Ugur, Dr. med.

Theresa Bernard, Dr. med.

Christian Schem, Prof. Dr.

Felix Hilpert, Prof. Dr.

Sabine Schmatloch, Dr.

Daniel Borries, Dr.

Sabine Schmatloch

Daniel Borries

Mustafa Deryal, Dr

Carolin Beckmann, Dr.

Mustafa Deryal

Carolin Beckmann

Patients with breast cancer, who have completed first line therapy (e.g., radiotherapy, chemotherapy, surgery), and who have to be identified with having a high risk of recurrence of cancer, will be eligible for the study. This patient group is currently offered a standard of care chemotherapy plus endocrine therapy (ET). The study investigates whether the patient group with high-risk early breast cancer benefits from treatment with the medication abemaciclib in combination with ET compared to ET alone.

The WSG ADAPT trial program is one of the first new generation trials addressing the issue of individualization of (neo)-adjuvant decision-making in early breast cancer (EBC) in a subtype-specific manner. The first WSG ADAPT umbrella trial (NCT01779206) aimed to establish early predictive molecular surrogate markers for response after a short 3-week induction treatment.

The goals of the WSG ADAPT trial program - early response assessment and subtype-specific therapy tailoring to those patients who are most likely to benefit - have contributed to the positive national and international feedback regarding the ADAPT-concept as a whole.

The aim of this ADAPTlate phase-III-trial is to gain further knowledge of the group of patients at intermediate to high risk for disease recurrence, who have completed definite locoregional therapy (with or without neoadjuvant or adjuvant chemotherapy). With ADAPTlate it is planned to investigate if the intermediate to high-risk patient group identified during the screening phase derives additional benefit from treatment with abemaciclib in combination with ET compared to ET alone.

multicenter, interventional, prospective, two-arm, randomized, open-label, controlled adjuvant, phase-III trial evaluating the efficacy and safety of abemaciclib with endocrine therapy (ET) versus standard-of-care endocrine therapy in early breast cancer (EBC) patients with molecular HR+/HER2- subtype.

Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC

Adj. 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- EBC

superiority in invasive disease-free survival (iDFS) of abemaciclib + endocrine therapy vs. standard-of-care endocrine therapy in patients with HR+/HER2- high risk breast cancer.

assessment of overall survival (OS) and distant DFS (dDFS) in both arms

differences in overall survival (OS) and dDFS between arms

subgroup and multivariable survival analyses

Eli Lilly and Company

Genomic Health®, Inc.

West German Study Group

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Overweight

Obesity

Overnutrition

Nutrition Disorders

Body Weight

Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals which they will be able to rate (like/dislike), along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.

The intervention is testing the feasibility of a reinforcement learning tool to pull in participants' behavioral data (calories, activity, and weight) and use this data along with participants' past behavioral goal achievements to deliver the type of message that should be most effective for a given participant at a given time. At each decision point (early morning, morning, midday, and evening on a daily basis), the system evaluates which intervention options a participant is eligible to receive, and randomly chooses one intervention option from that list. Then the participant is randomly assigned to either receive or not receive that intervention message (with a 50-50 probability).

ADAPT

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC	NCT04565054	Breast Cancer F...	Abemaciclib 50 ...	18 Years -	West German Study Group
Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions	NCT05751993	Overweight and ... Overweight Obesity	ADAPT	18 Years - 55 Years	UNC Lineberger Comprehensive Cancer Center
Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC	NCT04055493	Breast Cancer F...	Ribociclib 200M...	18 Years -	West German Study Group
Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions	NCT05751993	Overweight and ... Overweight Obesity	ADAPT	18 Years - 55 Years	UNC Lineberger Comprehensive Cancer Center
Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC	NCT04055493	Breast Cancer F...	Ribociclib 200M...	18 Years -	West German Study Group

Spots Global Cancer Trial Database for adapt

Every month we try and update this database with for adapt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for adapt

Every month we try and update this database with for adapt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for adapt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.