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Could a targeted pill keep High-Risk breast cancer at bay?

NCT ID NCT04565054

Disease control Sponsor: West German Study Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial studies whether adding the drug abemaciclib (Verzenios) to standard hormone therapy helps prevent breast cancer from coming back in 1,260 women with high-risk, HR+/HER2- early breast cancer. Participants have already completed initial treatments like surgery or chemotherapy. The study compares the combination therapy to hormone therapy alone, tracking cancer recurrence and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abemaciclib (Verzenios)
What this could lead to
If successful, this could offer a new standard treatment to reduce the risk of breast cancer returning in high-risk patients.
What could go wrong
This is a phase 3 trial, but results are not yet available. Adding abemaciclib may cause side effects like diarrhea or fatigue, and it may not improve outcomes over standard therapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A. Prior to REGISTRATION 1\. 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. 4b. 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. 6\. 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). 7\. 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; * in patients with c/ypN0-1: * non-pCR in patients with G3 or c/ypN1 * high biological risk defined as G3 with Ki-67 ≥40% * or high genomic risk (RS\>25 (known or Oncotype Dx® in screening phase) or another test) * high CTS5 score or UICC stage IIb (clinical if neoadjuvant chemotherapy or pathological) OR, if patients do not fulfill above criteria: * patients ≤50 years old or pre-/perimenopausal and c or (y)pN1 disease (in particular if ET-non-response or no chemotherapy) * patients \>50 years old and postmenopausal and c or (y)pN1 with intermediate genomic risk (RS≥18) or non-low risk by another test ET non-response definition: Ki-67 post-treatment \> 10% (central or local pathology value) OR 8b. Patients after isolated locoregional relapse with high-risk patterns (e.g., rpT2-3 or rpN1-3 or G3 or Ki-67 pre-treatment ≥20%), once surgery with free margins was completed Note: Inclusion is only possible for the first locoregional relapse removed by surgery (free margins) OR 8c. Patients with any high clinical risk at Investigator´s assessment but not fulfilling above criteria: consultation with sponsor required B. Prior to RANDOMIZATION in the study 9. Completed primary therapy of breast cancer according to current guidelines, i.e., after (neo)adjuvant treatment, definite surgery and radiotherapy, if applicable. 10\. No clinical evidence of distant metastasis (confirmation recommended prior to randomization by either combination of or either one of the following examinations: CT thorax / abdomen, chest X-ray, liver ultrasound, bone scan, PET-CT). 11. Patient has available tumor tissue from primary diagnostic biopsy. 12. No contraindication for adjuvant ET. 13. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 14. Patient has adequate bone marrow and organ function as defined by the following laboratory values: * absolute neutrophil count ≥ 1.5 × 109/L, * platelets ≥ 100 × 109/L, * hemoglobin ≥ 8.0 g/dL, * total bilirubin ≤ 1.5 ULN, except for patients with Gilbert's Syndrome who may only be included if the total bilirubin is ≤ 2.0 × ULN or direct bilirubin within normal ranges, * aspartate transaminase (AST) ≤ 3 × ULN, * alanine transaminase (ALT) ≤ 3 × ULN, * serum creatinine ≤ 1.5 x ULN. 15. Ability to swallow abemaciclib tablets or to administer other study medication, respectively. 16\. Ability to communicate with the investigator and comply with study procedures. 17\. Willing to receive therapy by clinical site, as required by the protocol. Exclusion Criteria: Patients eligible for inclusion in this study must not meet any of the following criteria: 1. Patient with distant metastases of breast cancer beyond regional lymph nodes. 2. Previously received CDK 4/6 inhibitor. 3. Patient with a known hypersensitivity to any of the excipients of abemaciclib or standard-of-care endocrine therapy. 4. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects. 5. 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). 6. Patient has a concurrent malignancy or non-breast malignancy within 5 years prior to randomization. 7. 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). 8. 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. 9. 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.). 10. 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. 11. 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. 12. Participation in a prior investigational study within 30 days prior to enrollment. 13. Not able to understand and to comply with study instructions and requirements. 14. Pregnant or nursing (lactating) woman. 15. Woman of child-bearing potential defined as woman physiologically capable of becoming pregnant, unless she is using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment: 1. total abstinence (when this is in line with the preferred and usual lifestyle of the patient). 2. female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. 3. male partner sterilization (at least 6 months prior to study screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient. 4. placement of an intrauterine device (IUD). 5. use of condom + spermicide. 16. Use of oral (estrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer female

Contacts and locations

Locations

  • AGAPLESION Diakonie-Klinikum Hamburg Gyn. Studienambulanz

    Hamburg, 20259, Germany

  • Althaia Xarxa Assistencia

    Manresa, 08242, Spain

  • Brustzentrum Niederrhein, im ev. Krankenhaus Bethesda

    Mönchengladbach, North Rhine-Westphalia, 41061, Germany

  • Brustzentrum, Elisabeth-Krankenhaus gGmbH

    Kassel, Hesse, 34117, Germany

  • Caritas Traegergesellschaft Saarbruecken mbH (CTS) Frauenklinik

    Saarbrücken, Saarland, 66113, Germany

  • Centrum für Hämatologie und Onkologie

    Frankfurt a.M., Hesse, 60389, Germany

  • Christliches Klinikum Unna Mitte Gynäkologie und Geburtshilfe

    Unna, North Rhine-Westphalia, 59423, Germany

  • Complejo Hospitalario Universitario Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Consorcio Hospital General Universitario De Valencia

    Valencia, 46014, Spain

  • Diakovere Krankenhaus gGmbH Henriettenstift Frauenklinik

    Hanover, Lower Saxony, 30171, Germany

  • Evangelisches Krankenhaus Bergisch Gladbach gGmbH Brustzentrum,

    Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany

  • GRN-Klinik Weinheim Gynäkologie und Geburtshilfe

    Weinheim, Baden-Wurttemberg, 69469, Germany

  • GYNONOVA GbR Schwerpunktpraxis für gynäkologische Onkologie

    Cologne, North Rhine-Westphalia, 50679, Germany

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

    Dresden, Saxony, 01307, Germany

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Langen, Hesse, 63225, Germany

  • Gynäkologisches Zentrum Bonn PD Dr. med. Christian Kurbacher

    Bonn, North Rhine-Westphalia, 53111, Germany

  • HELIOS Klinikum Berlin-Buch GmbH

    Berlin, 13125, Germany

  • Haematologie-Onkologie im Zentrum MVZ GmbH

    Augsburg, Bavaria, 86150, Germany

  • Helios Universitätsklinikum Wuppertal Landesfrauenklinik

    Wuppertal, North Rhine-Westphalia, 42283, Germany

  • Hospital Beata Maria Ana

    Madrid, 28007, Spain

  • Hospital Quironsalud Sagrado Corazon

    Seville, 41013, Spain

  • Hospital Regional Universitario Malaga

    Málaga, 29010, Spain

  • Hospital Universitari Son Espases

    Palma, Mallorca, 7120, Spain

  • Hospital Universitario De Navarra

    Pamplona, 31008, Spain

  • Hospital Universitario San Juan De Alicante

    Sant Joan d'Alacant, 03550, Spain

  • Hospital Universitario San Pedro De Alcantara

    Cáceres, 10003, Spain

  • Hospital Universitario de Vinalopo

    Elche, 03293, Spain

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

    Barcelona, 08035, Spain

  • Hämatologisch-Onkologische Schwerpunktpraxis Würzburg & Kitzingen

    Würzburg, Bavaria, 97080, Germany

  • Johannes Wesling Klinikum Minden Innere Medizin, Hämatologie, Onkologie

    Minden, North Rhine-Westphalia, 32429, Germany

  • Johanniter Krankenhaus Frauenklinik

    Stendal, Saxony-Anhalt, 39576, Germany

  • Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum

    Essen, North Rhine-Westphalia, 45136, Germany

  • Kliniken der Stadt Köln Krankenhaus Köln-Holweide Medizinische Klinik Brustzentrum

    Cologne, North Rhine-Westphalia, 51067, Germany

  • Klinikum Chemnitz Frauenheilkunde und Geburtshilfe

    Chemnitz, Saxony, 09116, Germany

  • Klinikum Ernst von Bergmann gGmbH Brustzentrum

    Potsdam, Brandenburg, 14467, Germany

  • Klinikum Magdeburg Frauenheilkunde und Geburtshilfe

    Magdeburg, Saxony-Anhalt, 39130, Germany

  • Klinikum Mittelbaden Balg

    Baden-Baden, Baden-Würtemberg, 76532, Germany

  • Klinikum Mutterhaus der Borromäerinnen Innere Medizin 1

    Trier, Rhineland-Palatinate, 54290, Germany

  • Klinikum Obergöltzsch Brustzentrum Vogtland

    Rodewisch, Saxony, 08228, Germany

  • Klinikum St. Georg Gynäkologie und Geburtshilfe

    Leipzig, Saxony, 04129, Germany

  • Klinikum Südstadt Rostock Frauenklinik

    Rostock, Mecklenburg-Vorpommern, 18059, Germany

  • Klinikum der Universität München Campus Großhadern Frauenheilunde und Geburtsklinik

    Munich, Bavaria, 80336, Germany

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

    Warsaw, 02-781, Poland

  • MVM Medizinische Verwaltungs und Managementgesellschaft mbH

    Leer, Lower Saxony, 26789, Germany

  • MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie

    Georgsmarienhütte, Lower Saxony, 49124, Germany

  • MVZ Medical Center Duesseldorf GmbH Luisenkrankenhaus Brustzentrum

    Düsseldorf, North Rhine-Westphalia, 40235, Germany

  • MVZ Onkologische Kooperation Harz (GbR)

    Goslar, Lower Saxony, 38642, Germany

  • MVZ für Hämatologie und Onkologie

    Ravensburg, Baden-Wurttemberg, 88212, Germany

  • Mammazentrum Hamburg MVZ GbR

    Hamburg, 20357, Germany

  • Marien Hospital Witten Brustzentrum

    Witten, North Rhine-Westphalia, 58452, Germany

  • Marien Krankenhaus Schwerte MKS St. Paulus GmbH

    Schwerte, North Rhine-Westphalia, 58239, Germany

  • MediOnko-Institut GbR Praxiskliik Krebsheilkunde für Frauen/Brustzentrum

    Berlin, 10367, Germany

  • Medizinische Hochschule Hannover Frauenheilkunde

    Hanover, Lower Saxony, 30625, Germany

  • Medizinische Universität Lausitz - Carl-Thiem Frauenklinik

    Cottbus, Brandenburg, 03048, Germany

  • Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH

    Munich, Bavaria, 80639, Germany

  • Onkodok GmbH Onkologische Schwerpunktpraxis

    Gütersloh, North Rhine-Westphalia, 33332, Germany

  • Onkologisch-Hämatologische Schwerpunktpraxis

    Bremen, 28209, Germany

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, North Rhine-Westphalia, 33604, Germany

  • Onkozentrum Dresden/Freiberg/Meißen

    Dresden, Saxony, 01127, Germany

  • Pius-Hospital Oldenburg Hämatologie, Onkologie

    Oldenburg, Lower Saxony, 26121, Germany

  • Praxis für gynäkologische Onkologie im Brustzentrum City am Sankt Gertrauden KH

    Berlin, 10713, Germany

  • Praxis für interdisziplinäre Onkologie & Hämatologie

    Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

  • Praxisgemeinschaft Gynäkologische Onkologie & Spezielle Operative Gynäkologie

    Hildesheim, North Rhine-Westphalia, 31134, Germany

  • Praxisklinik für Hämatologie und Onkologie Koblenz

    Koblenz, Rhineland-Palatinate, 56068, Germany

  • Praxisnetz Hämatologie / internistische Onkologie

    Troisdorf, North Rhine-Westphalia, 53840, Germany

  • Rotkreuzkliniken München, Interdisziplinbäres Brustzentrum

    München, Bavaria, 80637, Germany

  • SLK Kliniken Heilbronn Klinik für Gynäkologie und Geburtshilfe

    Heilbronn, Baden-Wurttemberg, 74078, Germany

  • St. Elisabeth-Krankenhaus GmbH, Brustzentrum - Senologie

    Cologne, North Rhine-Westphalia, 50935, Germany

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

    Wiesbaden, Hesse, 65189, Germany

  • St.-Antonius-Hospital Eschweiler Hämatologie/Onkologie

    Eschweiler, North Rhine-Westphalia, 52249, Germany

  • Stiftung Katholisches BrustCentrum Marienhospital

    Aachen, North Rhine-Westphalia, 52066, Germany

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

    Braunschweig, Lower Saxony, 38100, Germany

  • Städtisches Klinikum Lüneburg Frauenklinik

    Lüneburg, North Rhine-Westphalia, 21339, Germany

  • Uniklinik RWTH Aachen Gynäkologie und Geburtsmedizin

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Universitätsklinikum Düsseldorf Frauenheilkunde und Geburtshilfe

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Universitätsklinikum Essen Frauenheilkunde und Geburtshilfe

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitätsklinikum Halle (UKH), Universitätsklinik und Poliklinik für Gynäkologie

    Halle, Saxony-Anhalt, 06120, Germany

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Frauenheilkunde

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Münster AöR Brustzentrum

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitätsklinikum Tübingen Department für Frauengesundheit, Brustzentrum

    Tübingen, Baden-Wüttenburg, 72076, Germany

  • Universitätsklinikum Ulm Frauenheilkunde, Geburtshilfe

    Ulm, Baden-Wurttemberg, 89075, Germany

  • Universitätsklinikum des Saarlandes Klinik für Frauenheilkunde

    Homburg (Saar), Saarland, 66421, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-211, Poland

  • Uniwersytet Jagiellonski Collegium Medicum Szpital Uniwersytecki w Krakowie - Klinika Onkologii

    Krakow, 31-864, Poland

  • Zentrum für ambulante gynäkologisch Onkologie (ZAGO)

    Krefeld, North Rhine-Westphalia, 47805, Germany

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