AzTrials
AzTrials

Breast Cancer FemalePhase 3ADAPTlateNCT04565054

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

A Phase 3 study testing Abemaciclib 50 MG; 150mg 1-0-1 per os in people with Breast Cancer Female, run by Women's Cancer Study Group GmbH at 85 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
Abemaciclib 50 MG; 150mg 1-0-1 per os
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,260 participants
Where
85 sitesin 3 countries
Study dates
2 Sep 2020to Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 36Show fewer
  • 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
  • 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.

Who cannot join

  • Patients eligible for inclusion in this study must not meet any of the following criteria:
  • 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).
Show all 23Show fewer
  • 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.
  • 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:
  • total abstinence (when this is in line with the preferred and usual lifestyle of the patient).
  • female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment.
  • 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.
  • placement of an intrauterine device (IUD).
  • use of condom + spermicide.
  • Use of oral (estrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy.

Trial locations and contacts

85 sites in 3 countries.

85 sites in 3 countries

Germany70 sites

  • Stiftung Katholisches BrustCentrum Marienhospital

    Aachen, North Rhine-Westphalia, 52066

  • Uniklinik RWTH Aachen Gynäkologie und Geburtsmedizin

    Aachen, North Rhine-Westphalia, 52074

  • Haematologie-Onkologie im Zentrum MVZ GmbH

    Augsburg, Bavaria, 86150

  • Klinikum Mittelbaden Balg

    Baden-Baden, Baden-Würtemberg, 76532

  • Evangelisches Krankenhaus Bergisch Gladbach gGmbH Brustzentrum,

    Bergisch Gladbach, North Rhine-Westphalia, 51465

  • MediOnko-Institut GbR Praxiskliik Krebsheilkunde für Frauen/Brustzentrum

    Berlin, 10367

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

    Berlin, 10713

  • HELIOS Klinikum Berlin-Buch GmbH

    Berlin, 13125

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, North Rhine-Westphalia, 33604

  • Gynäkologisches Zentrum Bonn PD Dr. med. Christian Kurbacher

    Bonn, North Rhine-Westphalia, 53111

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

    Braunschweig, Lower Saxony, 38100

  • Onkologisch-Hämatologische Schwerpunktpraxis

    Bremen, 28209

  • Klinikum Chemnitz Frauenheilkunde und Geburtshilfe

    Chemnitz, Saxony, 09116

  • GYNONOVA GbR Schwerpunktpraxis für gynäkologische Onkologie

    Cologne, North Rhine-Westphalia, 50679

  • St. Elisabeth-Krankenhaus GmbH, Brustzentrum - Senologie

    Cologne, North Rhine-Westphalia, 50935

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

    Cologne, North Rhine-Westphalia, 51067

  • Medizinische Universität Lausitz - Carl-Thiem Frauenklinik

    Cottbus, Brandenburg, 03048

  • Onkozentrum Dresden/Freiberg/Meißen

    Dresden, Saxony, 01127

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

    Dresden, Saxony, 01307

  • Universitätsklinikum Düsseldorf Frauenheilkunde und Geburtshilfe

    Düsseldorf, North Rhine-Westphalia, 40225

  • MVZ Medical Center Duesseldorf GmbH Luisenkrankenhaus Brustzentrum

    Düsseldorf, North Rhine-Westphalia, 40235

  • St.-Antonius-Hospital Eschweiler Hämatologie/Onkologie

    Eschweiler, North Rhine-Westphalia, 52249

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

    Essen, North Rhine-Westphalia, 45136

  • Universitätsklinikum Essen Frauenheilkunde und Geburtshilfe

    Essen, North Rhine-Westphalia, 45147

  • Centrum für Hämatologie und Onkologie

    Frankfurt a.M., Hesse, 60389

  • Praxis für interdisziplinäre Onkologie & Hämatologie

    Freiburg im Breisgau, Baden-Wurttemberg, 79110

  • MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie

    Georgsmarienhütte, Lower Saxony, 49124

  • MVZ Onkologische Kooperation Harz (GbR)

    Goslar, Lower Saxony, 38642

  • Onkodok GmbH Onkologische Schwerpunktpraxis

    Gütersloh, North Rhine-Westphalia, 33332

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

    Halle, Saxony-Anhalt, 06120

  • AGAPLESION Diakonie-Klinikum Hamburg Gyn. Studienambulanz

    Hamburg, 20259

  • Mammazentrum Hamburg MVZ GbR

    Hamburg, 20357

  • Diakovere Krankenhaus gGmbH Henriettenstift Frauenklinik

    Hanover, Lower Saxony, 30171

  • Medizinische Hochschule Hannover Frauenheilkunde

    Hanover, Lower Saxony, 30625

  • SLK Kliniken Heilbronn Klinik für Gynäkologie und Geburtshilfe

    Heilbronn, Baden-Wurttemberg, 74078

  • Praxisgemeinschaft Gynäkologische Onkologie & Spezielle Operative Gynäkologie

    Hildesheim, North Rhine-Westphalia, 31134

  • Universitätsklinikum des Saarlandes Klinik für Frauenheilkunde

    Homburg (Saar), Saarland, 66421

  • Brustzentrum, Elisabeth-Krankenhaus gGmbH

    Kassel, Hesse, 34117

  • Praxisklinik für Hämatologie und Onkologie Koblenz

    Koblenz, Rhineland-Palatinate, 56068

  • Zentrum für ambulante gynäkologisch Onkologie (ZAGO)

    Krefeld, North Rhine-Westphalia, 47805

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Langen, Hesse, 63225

  • MVM Medizinische Verwaltungs und Managementgesellschaft mbH

    Leer, Lower Saxony, 26789

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Frauenheilkunde

    Leipzig, Saxony, 04103

  • Klinikum St. Georg Gynäkologie und Geburtshilfe

    Leipzig, Saxony, 04129

  • Städtisches Klinikum Lüneburg Frauenklinik

    Lüneburg, North Rhine-Westphalia, 21339

  • Klinikum Magdeburg Frauenheilkunde und Geburtshilfe

    Magdeburg, Saxony-Anhalt, 39130

  • Johannes Wesling Klinikum Minden Innere Medizin, Hämatologie, Onkologie

    Minden, North Rhine-Westphalia, 32429

  • Brustzentrum Niederrhein, im ev. Krankenhaus Bethesda

    Mönchengladbach, North Rhine-Westphalia, 41061

  • Rotkreuzkliniken München, Interdisziplinbäres Brustzentrum

    München, Bavaria, 80637

  • Klinikum der Universität München Campus Großhadern Frauenheilunde und Geburtsklinik

    Munich, Bavaria, 80336

  • Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH

    Munich, Bavaria, 80639

  • Universitätsklinikum Münster AöR Brustzentrum

    Münster, North Rhine-Westphalia, 48149

  • Pius-Hospital Oldenburg Hämatologie, Onkologie

    Oldenburg, Lower Saxony, 26121

  • Klinikum Ernst von Bergmann gGmbH Brustzentrum

    Potsdam, Brandenburg, 14467

  • MVZ für Hämatologie und Onkologie

    Ravensburg, Baden-Wurttemberg, 88212

  • Klinikum Obergöltzsch Brustzentrum Vogtland

    Rodewisch, Saxony, 08228

  • Klinikum Südstadt Rostock Frauenklinik

    Rostock, Mecklenburg-Vorpommern, 18059

  • Caritas Traegergesellschaft Saarbruecken mbH (CTS) Frauenklinik

    Saarbrücken, Saarland, 66113

  • Marien Krankenhaus Schwerte MKS St. Paulus GmbH

    Schwerte, North Rhine-Westphalia, 58239

  • Johanniter Krankenhaus Frauenklinik

    Stendal, Saxony-Anhalt, 39576

  • Klinikum Mutterhaus der Borromäerinnen Innere Medizin 1

    Trier, Rhineland-Palatinate, 54290

  • Praxisnetz Hämatologie / internistische Onkologie

    Troisdorf, North Rhine-Westphalia, 53840

  • Universitätsklinikum Tübingen Department für Frauengesundheit, Brustzentrum

    Tübingen, Baden-Wüttenburg, 72076

  • Universitätsklinikum Ulm Frauenheilkunde, Geburtshilfe

    Ulm, Baden-Wurttemberg, 89075

  • Christliches Klinikum Unna Mitte Gynäkologie und Geburtshilfe

    Unna, North Rhine-Westphalia, 59423

  • GRN-Klinik Weinheim Gynäkologie und Geburtshilfe

    Weinheim, Baden-Wurttemberg, 69469

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

    Wiesbaden, Hesse, 65189

  • Marien Hospital Witten Brustzentrum

    Witten, North Rhine-Westphalia, 58452

  • Helios Universitätsklinikum Wuppertal Landesfrauenklinik

    Wuppertal, North Rhine-Westphalia, 42283

  • Hämatologisch-Onkologische Schwerpunktpraxis Würzburg & Kitzingen

    Würzburg, Bavaria, 97080

Other trials in Germany

Spain12 sites

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

    Barcelona, 08035

  • Hospital Universitario San Pedro De Alcantara

    Cáceres, 10003

  • Hospital Universitario de Vinalopo

    Elche, 03293

  • Hospital Beata Maria Ana

    Madrid, 28007

  • Hospital Regional Universitario Malaga

    Málaga, 29010

  • Althaia Xarxa Assistencia

    Manresa, 08242

  • Hospital Universitari Son Espases

    Palma, Mallorca, 7120

  • Hospital Universitario De Navarra

    Pamplona, 31008

  • Hospital Universitario San Juan De Alicante

    Sant Joan d'Alacant, 03550

  • Complejo Hospitalario Universitario Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Quironsalud Sagrado Corazon

    Seville, 41013

  • Consorcio Hospital General Universitario De Valencia

    Valencia, 46014

Other trials in Spain

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-211

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

    Krakow, 31-864

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

    Warsaw, 02-781

Other trials in Poland

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
Abemaciclib 50 MG; 150mg 1-0-1 per os
Keywords
early breast cancer, ADAPT, endocrine therapy, abemaciclib, high risk, HER2 negative, HR positive
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abemaciclib 50 MG; 150mg 1-0-1 per osDrug

    Also called Verzenios

    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

Study groups in NCT04565054
Study groupRoleWhat they receive
Abemaciclib plus ETExperimentalAbemaciclib 150 mg, 2 x daily, resulting in 300 mg/day, oral, 24 months plus endocrine treatment of physician´s choice
Receives: Drug: Abemaciclib 50 MG; 150mg 1-0-1 per os
Standard-of-care ETNo interventionStandard-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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. overall survival (OS)

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

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

  2. differences in overall survival (OS) and dDFS

    differences in overall survival (OS) and dDFS between arms

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

  3. subgroup and multivariable survival analyses

    subgroup and multivariable survival analyses

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

  4. CNS metastases

    occurrence of CNS metastases

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

  5. EORTC QLQ-C30

    quality of life (QoL)

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

  6. EORTC QLQ-BR23

    quality of life (QoL)

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

  7. EQ-5D-5L

    quality of life (QoL)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start2 Sep 2020
  3. Primary completionJun 2028 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
1,260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04565054
Sponsor's protocol ID
WSG-AM11 (ADAPTlate)
Other IDs
2019-001488-60, 2019
Acronym
ADAPTlate
Status last verified
Nov 2025
First submitted
7 Jul 2020
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abemaciclib 50 MG; 150mg 1-0-1 per os in people with Breast Cancer Female, run by Women's Cancer Study Group GmbH at 85 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in Germany, Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

invasive disease-free survival (iDFS) (time frame: at end of study, 3-6 years after start of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04565054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in