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

NCT04565054 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: WSG-AM11 (ADAPTlate)2019-001488-60
• Study Type: interventional
• Target: 1,260
• Locations: 3 countries
• Sites: 85

Brief Summary

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.

Conditions

Breast Cancer Female

Keywords

early breast cancer; ADAPT; endocrine therapy; abemaciclib; high risk; HER2 negative; HR positive

Outcome Measures

Primary Outcomes (1)

• invasive disease-free survival (iDFS)

  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.

  at end of study, 3-6 years after start of study treatment

Secondary Outcomes (7)

• overall survival (OS)

  at end of study, 3-6 years after start of treatment

• differences in overall survival (OS) and dDFS

  at end of study, 3-6 years after start of study treatment

• subgroup and multivariable survival analyses

  at end of study, 3-6 years after start of study treatment

• CNS metastases

  at end of study, 3-6 years after start of study treatment

• EORTC QLQ-C30

  at end of study, on average 3-6 years after start of treatment

Study Arms (2)

Abemaciclib plus ET

EXPERIMENTAL

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

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

Standard-of-care ET

NO INTERVENTION

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

Interventions

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

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

Also known as: Verzenios

Abemaciclib plus ET

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Prior to REGISTRATION
• \. Written informed consent prior to any study procedures (outcomes of standard-of-care procedures performed before signing of informed consent by the patient but within allowed screening period can be used for screening of patient). 2. Female. 3. ≥ 18 years of age. 4a. EITHER: (Post)menopausal status at the time of initiation of adjuvant study medication
• patient underwent bilateral oophorectomy, or
• age ≥ 60, or
• age \< 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, or ovarian suppression) and/or FSH and estradiol in the postmenopausal range per local normal range.
• b. OR: Pre-/perimenopausal patients:
• confirmed negative serum or urine pregnancy test (β-hCG) before starting study treatment, or
• patient has had a hysterectomy. 5. Histologically confirmed diagnosis(by local laboratory ) of estrogen-receptor positive and/or progesterone-receptor positive (\>1% ) primary early breast cancer or local relapse. In case the receptor status from local pathology is unclear a central pathology review is obligatory. Results must be known prior to randomization.
• \. Patient has HER2-negative breast cancer defined as
• a negative in-situ hybridization test or an IHC status of 0, 1+, or 2+,
• if IHC is 2+, a negative in-situ hybridization (FISH, CISH, or SISH) test is required (based on the analyzed tissue sample at initial diagnosis by a local laboratory).
• \. Patients are eligible
• with completed (i.e., 5 years according to SoC), planned or ongoing adjuvant endocrine therapy, without any signs of distant relapse or secondary malignancy AND
• if primary diagnosis was 6 years or less before enrollment 8a. Intermediate to high clinical or genomic risk, defined as either one of the following criteria:
• c or p or ypN 2-3 with/without (neo)adjuvant chemotherapy;

You may not qualify if:

• Patient with distant metastases of breast cancer beyond regional lymph nodes.
• Previously received CDK 4/6 inhibitor.
• Patient with a known hypersensitivity to any of the excipients of abemaciclib or standard-of-care endocrine therapy.
• Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
• Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤ 1 (polyneuropathy ≤ 2 is allowed).
• Patient has a concurrent malignancy or non-breast malignancy within 5 years prior to randomization.
• Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small-bowel resection).
• Patient has any active systemic bacterial infection (requiring intravenous antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
• Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator´s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study, or compromise compliance with the protocol (e.g., interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea, etc.).
• Patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
• Patient is currently receiving any of the following substances, which cannot be discontinued 7 days prior to day 1 of study treatment:
• o concomitant medications and herbal supplements, that are strong inducers or inhibitors of CYP3A4.
• Participation in a prior investigational study within 30 days prior to enrollment.
• Not able to understand and to comply with study instructions and requirements.
• Pregnant or nursing (lactating) woman.

Sponsors & Collaborators

• West German Study Group: lead
• Eli Lilly and Company: collaborator
• Genomic Health®, Inc.: collaborator

Study Sites (85)

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

Location

SLK Kliniken Heilbronn Klinik für Gynäkologie und Geburtshilfe

Heilbronn, Baden-Wurttemberg, 74078, Germany

Location

MVZ für Hämatologie und Onkologie

Ravensburg, Baden-Wurttemberg, 88212, Germany

Location

Universitätsklinikum Ulm Frauenheilkunde, Geburtshilfe

Ulm, Baden-Wurttemberg, 89075, Germany

Location

GRN-Klinik Weinheim Gynäkologie und Geburtshilfe

Weinheim, Baden-Wurttemberg, 69469, Germany

Location

Klinikum Mittelbaden Balg

Baden-Baden, Baden-Würtemberg, 76532, Germany

Location

Universitätsklinikum Tübingen Department für Frauengesundheit, Brustzentrum

Tübingen, Baden-Wüttenburg, 72076, Germany

Location

Haematologie-Onkologie im Zentrum MVZ GmbH

Augsburg, Bavaria, 86150, Germany

Location

Klinikum der Universität München Campus Großhadern Frauenheilunde und Geburtsklinik

Munich, Bavaria, 80336, Germany

Location

Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH

Munich, Bavaria, 80639, Germany

Location

Rotkreuzkliniken München, Interdisziplinbäres Brustzentrum

München, Bavaria, 80637, Germany

Location

Hämatologisch-Onkologische Schwerpunktpraxis Würzburg & Kitzingen

Würzburg, Bavaria, 97080, Germany

Location

Medizinische Universität Lausitz - Carl-Thiem Frauenklinik

Cottbus, Brandenburg, 03048, Germany

Location

Klinikum Ernst von Bergmann gGmbH Brustzentrum

Potsdam, Brandenburg, 14467, Germany

Location

Centrum für Hämatologie und Onkologie

Frankfurt a.M., Hesse, 60389, Germany

Location

Brustzentrum, Elisabeth-Krankenhaus gGmbH

Kassel, Hesse, 34117, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Langen, Hesse, 63225, Germany

Location

St. Josefs-Hospital Wiesbaden GmbH Ambulanz der Frauenklinik, Brustzentrum

Wiesbaden, Hesse, 65189, Germany

Location

Studien GbR Braunschweig Dr. Lorenz/Dr. Kreiss-Sender

Braunschweig, Lower Saxony, 38100, Germany

Location

MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie

Georgsmarienhütte, Lower Saxony, 49124, Germany

Location

MVZ Onkologische Kooperation Harz (GbR)

Goslar, Lower Saxony, 38642, Germany

Location

Diakovere Krankenhaus gGmbH Henriettenstift Frauenklinik

Hanover, Lower Saxony, 30171, Germany

Location

Medizinische Hochschule Hannover Frauenheilkunde

Hanover, Lower Saxony, 30625, Germany

Location

MVM Medizinische Verwaltungs und Managementgesellschaft mbH

Leer, Lower Saxony, 26789, Germany

Location

Pius-Hospital Oldenburg Hämatologie, Onkologie

Oldenburg, Lower Saxony, 26121, Germany

Location

Klinikum Südstadt Rostock Frauenklinik

Rostock, Mecklenburg-Vorpommern, 18059, Germany

Location

Stiftung Katholisches BrustCentrum Marienhospital

Aachen, North Rhine-Westphalia, 52066, Germany

Location

Uniklinik RWTH Aachen Gynäkologie und Geburtsmedizin

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Evangelisches Krankenhaus Bergisch Gladbach gGmbH Brustzentrum,

Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany

Location

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, North Rhine-Westphalia, 33604, Germany

Location

Gynäkologisches Zentrum Bonn PD Dr. med. Christian Kurbacher

Bonn, North Rhine-Westphalia, 53111, Germany

Location

GYNONOVA GbR Schwerpunktpraxis für gynäkologische Onkologie

Cologne, North Rhine-Westphalia, 50679, Germany

Location

St. Elisabeth-Krankenhaus GmbH, Brustzentrum - Senologie

Cologne, North Rhine-Westphalia, 50935, Germany

Location

Kliniken der Stadt Köln Krankenhaus Köln-Holweide Medizinische Klinik Brustzentrum

Cologne, North Rhine-Westphalia, 51067, Germany

Location

Universitätsklinikum Düsseldorf Frauenheilkunde und Geburtshilfe

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MVZ Medical Center Duesseldorf GmbH Luisenkrankenhaus Brustzentrum

Düsseldorf, North Rhine-Westphalia, 40235, Germany

Location

St.-Antonius-Hospital Eschweiler Hämatologie/Onkologie

Eschweiler, North Rhine-Westphalia, 52249, Germany

Location

Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum

Essen, North Rhine-Westphalia, 45136, Germany

Location

Universitätsklinikum Essen Frauenheilkunde und Geburtshilfe

Essen, North Rhine-Westphalia, 45147, Germany

Location

Onkodok GmbH Onkologische Schwerpunktpraxis

Gütersloh, North Rhine-Westphalia, 33332, Germany

Location

Praxisgemeinschaft Gynäkologische Onkologie & Spezielle Operative Gynäkologie

Hildesheim, North Rhine-Westphalia, 31134, Germany

Location

Zentrum für ambulante gynäkologisch Onkologie (ZAGO)

Krefeld, North Rhine-Westphalia, 47805, Germany

Location

Städtisches Klinikum Lüneburg Frauenklinik

Lüneburg, North Rhine-Westphalia, 21339, Germany

Location

Johannes Wesling Klinikum Minden Innere Medizin, Hämatologie, Onkologie

Minden, North Rhine-Westphalia, 32429, Germany

Location

Brustzentrum Niederrhein, im ev. Krankenhaus Bethesda

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

Universitätsklinikum Münster AöR Brustzentrum

Münster, North Rhine-Westphalia, 48149, Germany

Location

Marien Krankenhaus Schwerte MKS St. Paulus GmbH

Schwerte, North Rhine-Westphalia, 58239, Germany

Location

Praxisnetz Hämatologie / internistische Onkologie

Troisdorf, North Rhine-Westphalia, 53840, Germany

Location

Christliches Klinikum Unna Mitte Gynäkologie und Geburtshilfe

Unna, North Rhine-Westphalia, 59423, Germany

Location

Marien Hospital Witten Brustzentrum

Witten, North Rhine-Westphalia, 58452, Germany

Location

Helios Universitätsklinikum Wuppertal Landesfrauenklinik

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

Praxisklinik für Hämatologie und Onkologie Koblenz

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

Klinikum Mutterhaus der Borromäerinnen Innere Medizin 1

Trier, Rhineland-Palatinate, 54290, Germany

Location

Universitätsklinikum des Saarlandes Klinik für Frauenheilkunde

Homburg (Saar), Saarland, 66421, Germany

Location

Caritas Traegergesellschaft Saarbruecken mbH (CTS) Frauenklinik

Saarbrücken, Saarland, 66113, Germany

Location

Klinikum Chemnitz Frauenheilkunde und Geburtshilfe

Chemnitz, Saxony, 09116, Germany

Location

Onkozentrum Dresden/Freiberg/Meißen

Dresden, Saxony, 01127, Germany

Location

Gemeinschaftspraxis Dr. med. Johannes Mohm, Dr. med. Virág Siklaky, Stefanie Mann Onkopraxis Dresden

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Leipzig, Klinik und Poliklinik für Frauenheilkunde

Leipzig, Saxony, 04103, Germany

Location

Klinikum St. Georg Gynäkologie und Geburtshilfe

Leipzig, Saxony, 04129, Germany

Location

Klinikum Obergöltzsch Brustzentrum Vogtland

Rodewisch, Saxony, 08228, Germany

Location

Universitätsklinikum Halle (UKH), Universitätsklinik und Poliklinik für Gynäkologie

Halle, Saxony-Anhalt, 06120, Germany

Location

Klinikum Magdeburg Frauenheilkunde und Geburtshilfe

Magdeburg, Saxony-Anhalt, 39130, Germany

Location

Johanniter Krankenhaus Frauenklinik

Stendal, Saxony-Anhalt, 39576, Germany

Location

MediOnko-Institut GbR Praxiskliik Krebsheilkunde für Frauen/Brustzentrum

Berlin, 10367, Germany

Location

Praxis für gynäkologische Onkologie im Brustzentrum City am Sankt Gertrauden KH

Berlin, 10713, Germany

Location

HELIOS Klinikum Berlin-Buch GmbH

Berlin, 13125, Germany

Location

Onkologisch-Hämatologische Schwerpunktpraxis

Bremen, 28209, Germany

Location

AGAPLESION Diakonie-Klinikum Hamburg Gyn. Studienambulanz

Hamburg, 20259, Germany

Location

Mammazentrum Hamburg MVZ GbR

Hamburg, 20357, Germany

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-211, Poland

Location

Uniwersytet Jagiellonski Collegium Medicum Szpital Uniwersytecki w Krakowie - Klinika Onkologii

Krakow, 31-864, Poland

Location

MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive Surgery

Warsaw, 02-781, Poland

Location

Hospital Universitari Son Espases

Palma, Mallorca, 7120, Spain

Location

Hospital Vall Hebron - Vall Hebron Institute of Oncology (VHIO)

Barcelona, 08035, Spain

Location

Hospital Universitario San Pedro De Alcantara

Cáceres, 10003, Spain

Location

Hospital Universitario de Vinalopo

Elche, 03293, Spain

Location

Hospital Beata Maria Ana

Madrid, 28007, Spain

Location

Althaia Xarxa Assistencia

Manresa, 08242, Spain

Location

Hospital Regional Universitario Malaga

Málaga, 29010, Spain

Location

Hospital Universitario De Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario San Juan De Alicante

Sant Joan d'Alacant, 03550, Spain

Location

Complejo Hospitalario Universitario Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Quironsalud Sagrado Corazon

Seville, 41013, Spain

Location

Consorcio Hospital General Universitario De Valencia

Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Oleg Gluz, PD Dr. med.

  Westdeutsche Studiengruppe GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: September 25, 2020
• Study Start: September 2, 2020
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (70); ES (12); PL (3)