Could a pill replace chemo for some breast cancer patients?

NCT ID NCT04055493

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a combination of ribociclib (a targeted pill) and hormone therapy works better than standard chemotherapy for women with a common type of early breast cancer (HR+/HER2-). About 1,684 women with intermediate-risk disease are taking part. The goal is to see which approach better prevents the cancer from coming back.

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

1,684 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Jul 2027

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: Patients eligible for inclusion in this study have to meet all of the following criteria: A. Prior to REGISTRATION in the study: 1\. Written informed consent prior to any screening procedures. 2. Female. 3. ≥ 18 years of age. 4a. EITHER: (Post)menopausal status at the time of initiation of (neo)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, toremifene, or ovarian suppression) and/or FSH and estradiol in the postmenopausal range per local normal range. 4b. OR: Pre-menopausal patients: * confirmed negative serum pregnancy test (β-hCG) before starting study treatment, or * patient has had a hysterectomy. 5. Histologically confirmed diagnosis of primary estrogen-receptor positive and/or progesterone-receptor positive (\> 1%) early breast cancer by local laboratory. 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 most recently analyzed tissue sample and all tested by a local laboratory). 7\. Local therapy of breast cancer (if adjuvant treatment or planned if neoadjuvant treatment) according to current guidelines. Note: This may include radiotherapy of breast cancer. B. Prior to RANDOMIZATION in the study 8. No evidence of distant metastasis (confirmed prior to randomization by, preferentially, CT thorax / abdomen, X-ray chest, ultrasound liver, bone scan, or PET-CT). 9\. Patient has available tumor tissue from diagnostic biopsy. 10. Patient is classified as intermediate risk according to the ADAPT intermediate-risk definition (i) (as follows), or (only in case of missing Oncotype DX or Ki-67 response data), according to the clinical intermediate-risk definition (ii) (as follows). (i). ADAPT intermediate-risk definition: Patient meets one of the following criteria: * c/pN0, RS ≤ 25 with luminal-B-like (Ki-67 ≥20% or G3) or c/pT2-4 without endocrine response (post-endocrine Ki-67 \> 10 %) * c/pN1, RS ≤ 25 without endocrine response (post-endocrine Ki-67 \> 10 %) * c/pN0, RS \> 25 with luminal-B-like (Ki-67 ≥20% or G3) or c/pT2-4 with endocrine response (Ki-67 ≤ 10 %) * c/pN1, RS \> 25 with endocrine response (Ki-67 ≤ 10 %) * c/pN2-3, RS ≤ 25 with endocrine response (Ki-67 ≤ 10 %). Note: Postmenopausal patients with pT1-2/pN0 disease and RS \< 25, as well as premenopausal patients with pT1-2/pN0 disease and RS\<16, are recommended to be treated by endocrine therapy alone and not to be randomized (at investigator´s discretion). (ii). Clinical intermediate-risk definition (ascertained by investigator): Clinical intermediate risk may be ascertained by the investigator prior to randomization if at maximum two of the following three risk factors are present (according to primary diagnosis / 1st sample): 1. cT2-4 2. c/pN positive 3. G3 and / or Ki-67 ≥ 20% Note: Inclusion of a patient according to "clinical intermediate risk" is permitted only in case of missing baseline Oncotype DX® or Ki-67 decrease. In this case, investigators will follow a risk-based, step-wise assessment process. 11\. No contraindication for (neo)-adjuvant ET. 12. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 13. 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 ≥ 9.0 g/dL, * estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by a Cockcroft-Gault formula, * INR ≤ 1.5, * serum creatinine \< 1.5 mg/dL, * total bilirubin \< ULN, except for patients with Gilbert's Syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN, * aspartate transaminase (AST) \< 2.5 × ULN, * alanine transaminase (ALT) \< 2.5 × ULN. 14. 2-lead-ECG (CANKADO) with: * QTcF interval at screening \< 450 msec (using Fridericia's correction), * mean resting heart rate 50-90 bpm (determined from the ECG). 15. Ability to swallow ribociclib tablets or to administer other study medication, respectively. 16\. Ability to communicate with the investigator and comply with study procedures. 17\. Willing to remain during therapy at the 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. Patient has received prior (neo)-adjuvant treatment with chemotherapy, ET, or any CDK4/6 inhibitor for breast cancer. 3. Patient has received tamoxifen, raloxifene, or aromatase inhibitors (AIs) for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within last 2 years prior to screening. 4. Patient has received prior neoadjuvant/adjuvant treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin. 5. Patient with a known hypersensitivity to any of the excipients of ribociclib, ET, or standard-of-care chemotherapy. 6. Patient with inflammatory breast cancer at screening. 7. Patient is concurrently using other anti-cancer therapy. 8. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects. 9. Patient is currently receiving warfarin or other coumarin-derived anti-coagulant for treatment, prophylaxis, or otherwise. 10. Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤ 1. 11. Patient has a concurrent malignancy, or malignancy within 5 years of randomization, or known history of invasive breast cancer. 12. 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). 13. Patient has a known history of HIV infection. 14. Patient has known active hepatitis-B-virus (HBV) or hepatitis-C-virus (HCV) infection. 15. 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., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial, or viral infections, etc.). 16. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following: * history of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry, * documented cardiomyopathy, * left ventricular ejection fraction (LVEF) \< 50 % as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO), * long QT syndrome, family history of idiopathic sudden death, congenital long QT syndrome, or any of the following: * risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/ symptomatic bradycardia, * concomitant medications with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug), * inability to determine the QTcF interval, * clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left-bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II, and 3rd-degree AV block), * systolic blood pressure (SBP) \> 160 or \< 90 mmHg. 17. Patient is currently receiving any of the following substances, which cannot be discontinued 7 days prior to Cycle 1 Day 1: * concomitant medications, herbal supplements, fruits (e.g. grapefruit, pomegranates, pomelos, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4/5, * medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. 18. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. 19. Participation in a prior investigational study within 30 days prior to enrollment or within five half-lives of the investigational product, whichever is longer. 20. Not able to understand and to comply with study instructions and requirements. 21. Pregnant or nursing (lactating) woman. 22. 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). 23. 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 Markus Krankenhaus / Brustzentrum Gynäkologie und Geburtshilfe

Frankfurt am Main, Hesse, 60431, Germany
Agaplesion Diakonieklinikum Hamburg Frauenklinik, Brustzentrum u. Gyn. Tumorzentrum / Gyn. Studienambulanz

Hamburg, Free and Hanseatic City of Hamburg, 20259, Germany
Altmark-Klinikum Salzwedel Klinik für Frauenheilkunde

Hansestadt Salzwedel, Saxony-Anhalt, 29410, Germany
Carl-Thiem-Klinikum / Brustzentrum Senologie der Frauenklinik

Cottbus, Brandenburg, 03048, Germany
Charité Berlin, Klinik für Gynäkologie m.S. Senologie Brustzentrum (CCM)

Berlin, State of Berlin, 10117, Germany
Christliches Klinikum Unna gGmbH Brustzentrum

Unna, North Rhine-Westphalia, 59423, Germany
DIAKOVERE Henriettenstift Frauenklinik

Hanover, Lower Saxony, 30559, Germany
DRK Kliniken Saar / Krankenhaus Saarlouis Brustzentrum

Saarlouis, Saarland, 66740, Germany
DRK Klinikum Berlin-Köpenick Brustzentrum

Berlin, State of Berlin, 12559, Germany
Diakonie Klinikum Jung Stilling Brustzentrum

Siegen, North Rhine-Westphalia, 57074, Germany
EVK Bergisch Gladbach Brustzentrum

Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany
Evangelische Kliniken Gelsenkirchen GmbH Klinik für Senologie

Gelsenkirchen, North Rhine-Westphalia, 45879, Germany
Evangelisches Waldkrankenhaus Spandau Klinik für Gynäkologie und Geburtshilfe

Berlin, State of Berlin, 13589, Germany
Frauenklinik und Poliklinik / Studienzentrale Josef-Schneider-Straße 4

Würzburg, Bavaria, 97080, Germany
Frauenärzte Casparistraße Studien GbR BS

Braunschweig, Lower Saxony, 38100, Germany
GRN Klinik Weinheim Gynäkologie

Weinheim, Baden-Wurttemberg, 69469, Germany
Gynäkologische Gemeinschaftspraxis-Ärztehaus am Bahnhofsplatz Klinische Studien

Hildesheim, Lower Saxony, 31134, Germany
Helios Universitätsklinikum Frauenheilkunde & Geburtshilfe

Wuppertal, North Rhine-Westphalia, 42283, Germany
Hämatologisch/Onkologische Schwerpunktpraxis Praxis Dr. Schreiber

Bremen, Free Hanseatic City of Bremen, 28209, Germany
Johanniter Frauenklinik Stendal Gynäkologie

Stendal, Saxony-Anhalt, 39576, Germany
Katholisches Klinikum Koblenz-Montabaur-Marienhof Koblenz Marienhof Koblenz - Gynäkologie

Koblenz, Rhineland-Palatinate, 56073, Germany
Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum

Essen, North Rhine-Westphalia, 45136, Germany
Kliniken St. Georg Klinik für Gynäkologie und Geburtshilfe

Leipzig, Saxony, 04129, Germany
Kliniken der Stadt Köln / Krankenhaus Holweide Brustzentrum Holweide

Cologne, North Rhine-Westphalia, 51067, Germany
Klinikum Bremerhaven Reinkenheide Frauenklinik

Bremerhaven, Free Hanseatic City of Bremen, 27574, Germany
Klinikum Chemnitz Frauenklinik / Brustzentrum

Chemnitz, Saxony, 09116, Germany
Klinikum Dortmund gGmbH Frauenklinik

Dortmund, North Rhine-Westphalia, 44137, Germany
Klinikum Ernst von Bergmann Klinik für Gynäkologie und Geburtshilfe

Potsdam, Brandenburg, 14467, Germany
Klinikum Frankfurt Höchst Klinik für Gynäkologie und Geburtshilfe

Frankfurt am Main, Hesse, 65929, Germany
Klinikum Kassel Frauenklinik

Kassel, Hesse, 34125, Germany
Klinikum Leverkusen Medizinische Klinik 3

Leverkusen, North Rhine-Westphalia, 51375, Germany
Klinikum Ludwigsburg Klinik für Frauenheilkunde u. Geburtshilfe

Ludwigsburg, Baden-Wurttemberg, 71640, Germany
Klinikum Mutterhaus der Borromäerinnen Innere Medizin I / Onkologie

Trier, Rhineland-Palatinate, 54290, Germany
Klinikum Obergöltzsch-Rodewisch Frauenklinik

Rodewisch, Saxony, 08228, Germany
Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Brustzentrum

Munich, Bavaria, 80337, Germany
Kreiskliniken Böblingen Klinikum Böblingen Frauenklinik

Böblingen, Baden-Wurttemberg, 71032, Germany
Luisenkrankenhaus GmbH GynOnco Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40235, Germany
MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie, Brustzenzrum

Georgsmarienhütte, Lower Saxony, 49124, Germany
MVZ Klinik Dr. Hancken Haematologie/Onkologie

Stade, Lower Saxony, 21680, Germany
MVZ Nordhausen Praxis Dr. Andrea Grafe

Nordhausen, Thuringia, 99734, Germany
Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, Free and Hanseatic City of Hamburg, 20357, Germany
Marien Hospital / Senologie Brustzentrum

Witten, North Rhine-Westphalia, 58452, Germany
Marien-Krankenhaus Klinik für Gynäkologie und Geburtshilfe

Siegen, North Rhine-Westphalia, 57072, Germany
Marienhospital Bottrop Klinik für Gynäkologie und Geburtshilfe / Gyn-Ambulanz

Bottrop, North Rhine-Westphalia, 46236, Germany
Marienhospital Studienzentrale BrustCentrum Aachen-Kreis Heinsberg

Aachen, North Rhine-Westphalia, 52066, Germany
Marienkrankenhaus Schwerte Brustzentrum

Schwerte, North Rhine-Westphalia, 58239, Germany
Medizinische Hochschulle Hannover Klinik für Frauenheilkunde und Geburtshilfe

Hanover, Lower Saxony, 30539, Germany
ONCOLOGIANOVA Praxis Dr. Emde

Recklinghausen, North Rhine-Westphalia, 45659, Germany
Onkodok GmbH

Gütersloh, North Rhine-Westphalia, 33332, Germany
Onkologische Schwerpunktpraxis Bielefeld Praxis Dr. Just

Bielefeld, North Rhine-Westphalia, 33604, Germany
Ost-Alb Klinikum Brustzentrum

Aalen, Baden-Wurttemberg, 73430, Germany
Praxis Dr. Adhami

Erkelenz, North Rhine-Westphalia, 41812, Germany
Praxis für Hämatologie und internistische Onkologie Praxis Dr. Nusch

Velbert, North Rhine-Westphalia, 42551, Germany
Praxis für gynäkologische Onkologie am Ev. Krankenhaus Bethesda

Mönchengladbach, North Rhine-Westphalia, 41061, Germany
Praxis für interdisziplinäre Onkologie & Hämatologie GbR Praxis am Diakonieklinikum

Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany
Praxisnetz Hämatologie / internistische Onkologie Praxis Troisdorf

Troisdorf, North Rhine-Westphalia, 53840, Germany
Rotkreuzkliniken München Frauenklinik - Gynäkologie

München, Bavaria, 80637, Germany
SLK-Kliniken-Heilbronn Frauenklinik

Heilbronn, Baden-Wurttemberg, 74078, Germany
Sana Klinikum Klinik für Gynäkologie und Geburtshilfe, Studienambulanz AOZ

Offenbach, Hesse, 63069, Germany
Schwerpunktpraxis Gynäkologische Onkologie Praxis Dr. Heinrich

Fürstenwalde, Brandenburg, 15517, Germany
St. Antonius Hospital Klinik für Hämatologie/Onkologie

Eschweiler, North Rhine-Westphalia, 52249, Germany
St. Barbara Klinik Brustzentrum

Hamm, North Rhine-Westphalia, 59073, Germany
St. Elisabeth-Krankenhaus Hohenlind Brustzentrum

Cologne, North Rhine-Westphalia, 50935, Germany
St. Franziskus-Hospital Brustzentrum

Münster, North Rhine-Westphalia, 48145, Germany
St. Gertrauden Krankenhaus Brustzentrum City Berlin

Berlin, State of Berlin, 10713, Germany
St. Josefs-Hospital Wiesbaden Frauenklinik - Gynäkologie

Wiesbaden, Hesse, 65189, Germany
Stadtklinik Baden-Baden Brustzentrum

Baden-Baden, Baden-Wurttemberg, 76532, Germany
Städtisches Klinikum Lüneburg Frauenklinik

Lüneburg, Lower Saxony, 21339, Germany
UFK Klinikum Südstadt Frauenklinik

Rostock, Mecklenburg-Vorpommern, 18059, Germany
UKE Hamburg / Frauenklinik Brustzentrum am UKE

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
Uniklinik Köln / Gebäude 70 Studienzentrale der Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

Cologne, North Rhine-Westphalia, 50937, Germany
Uniklinikum Freiburg Frauenklinik

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitätsfrauenklinik Ulm Frauenheilkunde und Geburtshilfe

Ulm, Baden-Wurttemberg, 89075, Germany
Universitätsklinikum Aachen, Frauenklinik - Senologie

Aachen, North Rhine-Westphalia, 52074, Germany
Universitätsklinikum Dresden Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

Dresden, Saxony, 01307, Germany
Universitätsklinikum Düsseldorf Klinik für Frauenheilkunde & Geburtshilfe

Düsseldorf, North Rhine-Westphalia, 40225, Germany
Universitätsklinikum Essen Klinik für Frauenheilkunde und Geburtshilfe

Essen, North Rhine-Westphalia, 45130, Germany
Universitätsklinikum Frauenheilkunde

Münster, North Rhine-Westphalia, 48149, Germany
Universitätsklinikum Halle Universitätsklinik für Gynäkologie

Halle, Saxony-Anhalt, 06120, Germany
Universitätsklinikum Jena Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin

Jena, Thuringia, 07747, Germany
Universitätsklinikum Leipzig Gynäkologie und Universitäres Krebszentrum; Klinik und Poliklinik für Frauenheilkunde

Leipzig, Saxony, 04015, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck, Frauenklinik

Lübeck, Schleswig-Holstein, 23538, Germany
Universitätsklinikum Tübingen Universitäts-Frauenklinik

Tübingen, Baden-Wurttemberg, 72016, Germany
Universitätsklinikum des Saarlandes Frauenklinik

Homburg, Saarland, 66421, Germany
Vivantes Klinikum Am Urban Brustzentrum

Berlin, State of Berlin, 10967, Germany
Wilhelm-Anton-Hospital Goch Klinik für Innere Medizin, Hämatologie u. Onkologie

Goch, North Rhine-Westphalia, 47574, Germany

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