AzTrials
AzTrials

Breast Cancer FemalePhase 3ADAPTcycleNCT04055493

Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

A Phase 3 study testing Ribociclib 200Mg Oral Tablet in people with Breast Cancer Female, run by Women's Cancer Study Group GmbH at 86 sites in Germany.

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

The study investigates, whether the patient group with intermediate-risk early breast cancer benefits from treatment with ribociclib in combination with endocrine therapy compared to standard-of-care chemotherapy (followed by adjuvant endocrine therapy). 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?
Ribociclib 200Mg Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,684 participants
Where
86 sitesGermany
Study dates
2 Jul 2019to 31 Jul 2027
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

  • Patients eligible for inclusion in this study have to meet all of the following criteria:
  • 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.
Show all 40Show fewer
  • 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.
  • 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):
  • cT2-4
  • c/pN positive
  • 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.

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.
  • Patient has received prior (neo)-adjuvant treatment with chemotherapy, ET, or any CDK4/6 inhibitor for breast cancer.
  • 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.
  • 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.
  • Patient with a known hypersensitivity to any of the excipients of ribociclib, ET, or standard-of-care chemotherapy.
Show all 39Show fewer
  • Patient with inflammatory breast cancer at screening.
  • Patient is concurrently using other anti-cancer therapy.
  • Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
  • Patient is currently receiving warfarin or other coumarin-derived anti-coagulant for treatment, prophylaxis, or otherwise.
  • Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤ 1.
  • Patient has a concurrent malignancy, or malignancy within 5 years of randomization, or known history of invasive breast cancer.
  • 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 a known history of HIV infection.
  • Patient has known active hepatitis-B-virus (HBV) or hepatitis-C-virus (HCV) infection.
  • 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.).
  • 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.
  • 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.
  • 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.
  • Participation in a prior investigational study within 30 days prior to enrollment or within five half-lives of the investigational product, whichever is longer.
  • 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 oral (estrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy.

Trial locations and contacts

86 sites in 1 country.

86 sites in 1 country

Germany86 sites

  • Marienhospital Studienzentrale BrustCentrum Aachen-Kreis Heinsberg

    Aachen, North Rhine-Westphalia, 52066

  • Universitätsklinikum Aachen, Frauenklinik - Senologie

    Aachen, North Rhine-Westphalia, 52074

  • Ost-Alb Klinikum Brustzentrum

    Aalen, Baden-Wurttemberg, 73430

  • Stadtklinik Baden-Baden Brustzentrum

    Baden-Baden, Baden-Wurttemberg, 76532

  • EVK Bergisch Gladbach Brustzentrum

    Bergisch Gladbach, North Rhine-Westphalia, 51465

  • Charité Berlin, Klinik für Gynäkologie m.S. Senologie Brustzentrum (CCM)

    Berlin, State of Berlin, 10117

  • St. Gertrauden Krankenhaus Brustzentrum City Berlin

    Berlin, State of Berlin, 10713

  • Vivantes Klinikum Am Urban Brustzentrum

    Berlin, State of Berlin, 10967

  • DRK Klinikum Berlin-Köpenick Brustzentrum

    Berlin, State of Berlin, 12559

  • Evangelisches Waldkrankenhaus Spandau Klinik für Gynäkologie und Geburtshilfe

    Berlin, State of Berlin, 13589

  • Onkologische Schwerpunktpraxis Bielefeld Praxis Dr. Just

    Bielefeld, North Rhine-Westphalia, 33604

  • Kreiskliniken Böblingen Klinikum Böblingen Frauenklinik

    Böblingen, Baden-Wurttemberg, 71032

  • Marienhospital Bottrop Klinik für Gynäkologie und Geburtshilfe / Gyn-Ambulanz

    Bottrop, North Rhine-Westphalia, 46236

  • Frauenärzte Casparistraße Studien GbR BS

    Braunschweig, Lower Saxony, 38100

  • Hämatologisch/Onkologische Schwerpunktpraxis Praxis Dr. Schreiber

    Bremen, Free Hanseatic City of Bremen, 28209

  • Klinikum Bremerhaven Reinkenheide Frauenklinik

    Bremerhaven, Free Hanseatic City of Bremen, 27574

  • Klinikum Chemnitz Frauenklinik / Brustzentrum

    Chemnitz, Saxony, 09116

  • St. Elisabeth-Krankenhaus Hohenlind Brustzentrum

    Cologne, North Rhine-Westphalia, 50935

  • Uniklinik Köln / Gebäude 70 Studienzentrale der Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

    Cologne, North Rhine-Westphalia, 50937

  • Kliniken der Stadt Köln / Krankenhaus Holweide Brustzentrum Holweide

    Cologne, North Rhine-Westphalia, 51067

  • Carl-Thiem-Klinikum / Brustzentrum Senologie der Frauenklinik

    Cottbus, Brandenburg, 03048

  • Klinikum Dortmund gGmbH Frauenklinik

    Dortmund, North Rhine-Westphalia, 44137

  • Universitätsklinikum Dresden Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

    Dresden, Saxony, 01307

  • Universitätsklinikum Düsseldorf Klinik für Frauenheilkunde & Geburtshilfe

    Düsseldorf, North Rhine-Westphalia, 40225

  • Luisenkrankenhaus GmbH GynOnco Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40235

  • Praxis Dr. Adhami

    Erkelenz, North Rhine-Westphalia, 41812

  • St. Antonius Hospital Klinik für Hämatologie/Onkologie

    Eschweiler, North Rhine-Westphalia, 52249

  • Universitätsklinikum Essen Klinik für Frauenheilkunde und Geburtshilfe

    Essen, North Rhine-Westphalia, 45130

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

    Essen, North Rhine-Westphalia, 45136

  • AGAPLESION Markus Krankenhaus / Brustzentrum Gynäkologie und Geburtshilfe

    Frankfurt am Main, Hesse, 60431

  • Klinikum Frankfurt Höchst Klinik für Gynäkologie und Geburtshilfe

    Frankfurt am Main, Hesse, 65929

  • Uniklinikum Freiburg Frauenklinik

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Praxis für interdisziplinäre Onkologie & Hämatologie GbR Praxis am Diakonieklinikum

    Freiburg im Breisgau, Baden-Wurttemberg, 79110

  • Schwerpunktpraxis Gynäkologische Onkologie Praxis Dr. Heinrich

    Fürstenwalde, Brandenburg, 15517

  • Evangelische Kliniken Gelsenkirchen GmbH Klinik für Senologie

    Gelsenkirchen, North Rhine-Westphalia, 45879

  • MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie, Brustzenzrum

    Georgsmarienhütte, Lower Saxony, 49124

  • Wilhelm-Anton-Hospital Goch Klinik für Innere Medizin, Hämatologie u. Onkologie

    Goch, North Rhine-Westphalia, 47574

  • Onkodok GmbH

    Gütersloh, North Rhine-Westphalia, 33332

  • Universitätsklinikum Halle Universitätsklinik für Gynäkologie

    Halle, Saxony-Anhalt, 06120

  • UKE Hamburg / Frauenklinik Brustzentrum am UKE

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Agaplesion Diakonieklinikum Hamburg Frauenklinik, Brustzentrum u. Gyn. Tumorzentrum / Gyn. Studienambulanz

    Hamburg, Free and Hanseatic City of Hamburg, 20259

  • Mammazentrum Hamburg am Krankenhaus Jerusalem

    Hamburg, Free and Hanseatic City of Hamburg, 20357

  • St. Barbara Klinik Brustzentrum

    Hamm, North Rhine-Westphalia, 59073

  • Medizinische Hochschulle Hannover Klinik für Frauenheilkunde und Geburtshilfe

    Hanover, Lower Saxony, 30539

  • DIAKOVERE Henriettenstift Frauenklinik

    Hanover, Lower Saxony, 30559

  • Altmark-Klinikum Salzwedel Klinik für Frauenheilkunde

    Hansestadt Salzwedel, Saxony-Anhalt, 29410

  • SLK-Kliniken-Heilbronn Frauenklinik

    Heilbronn, Baden-Wurttemberg, 74078

  • Gynäkologische Gemeinschaftspraxis-Ärztehaus am Bahnhofsplatz Klinische Studien

    Hildesheim, Lower Saxony, 31134

  • Universitätsklinikum des Saarlandes Frauenklinik

    Homburg, Saarland, 66421

  • Universitätsklinikum Jena Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin

    Jena, Thuringia, 07747

  • Klinikum Kassel Frauenklinik

    Kassel, Hesse, 34125

  • Katholisches Klinikum Koblenz-Montabaur-Marienhof Koblenz Marienhof Koblenz - Gynäkologie

    Koblenz, Rhineland-Palatinate, 56073

  • Universitätsklinikum Leipzig Gynäkologie und Universitäres Krebszentrum; Klinik und Poliklinik für Frauenheilkunde

    Leipzig, Saxony, 04015

  • Kliniken St. Georg Klinik für Gynäkologie und Geburtshilfe

    Leipzig, Saxony, 04129

  • Klinikum Leverkusen Medizinische Klinik 3

    Leverkusen, North Rhine-Westphalia, 51375

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck, Frauenklinik

    Lübeck, Schleswig-Holstein, 23538

  • Klinikum Ludwigsburg Klinik für Frauenheilkunde u. Geburtshilfe

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Städtisches Klinikum Lüneburg Frauenklinik

    Lüneburg, Lower Saxony, 21339

  • Praxis für gynäkologische Onkologie am Ev. Krankenhaus Bethesda

    Mönchengladbach, North Rhine-Westphalia, 41061

  • Rotkreuzkliniken München Frauenklinik - Gynäkologie

    München, Bavaria, 80637

  • Klinikum der Universität München Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Brustzentrum

    Munich, Bavaria, 80337

  • St. Franziskus-Hospital Brustzentrum

    Münster, North Rhine-Westphalia, 48145

  • Universitätsklinikum Frauenheilkunde

    Münster, North Rhine-Westphalia, 48149

  • MVZ Nordhausen Praxis Dr. Andrea Grafe

    Nordhausen, Thuringia, 99734

  • Sana Klinikum Klinik für Gynäkologie und Geburtshilfe, Studienambulanz AOZ

    Offenbach, Hesse, 63069

  • Klinikum Ernst von Bergmann Klinik für Gynäkologie und Geburtshilfe

    Potsdam, Brandenburg, 14467

  • ONCOLOGIANOVA Praxis Dr. Emde

    Recklinghausen, North Rhine-Westphalia, 45659

  • Klinikum Obergöltzsch-Rodewisch Frauenklinik

    Rodewisch, Saxony, 08228

  • UFK Klinikum Südstadt Frauenklinik

    Rostock, Mecklenburg-Vorpommern, 18059

  • DRK Kliniken Saar / Krankenhaus Saarlouis Brustzentrum

    Saarlouis, Saarland, 66740

  • Marienkrankenhaus Schwerte Brustzentrum

    Schwerte, North Rhine-Westphalia, 58239

  • Marien-Krankenhaus Klinik für Gynäkologie und Geburtshilfe

    Siegen, North Rhine-Westphalia, 57072

  • Diakonie Klinikum Jung Stilling Brustzentrum

    Siegen, North Rhine-Westphalia, 57074

  • MVZ Klinik Dr. Hancken Haematologie/Onkologie

    Stade, Lower Saxony, 21680

  • Johanniter Frauenklinik Stendal Gynäkologie

    Stendal, Saxony-Anhalt, 39576

  • Klinikum Mutterhaus der Borromäerinnen Innere Medizin I / Onkologie

    Trier, Rhineland-Palatinate, 54290

  • Praxisnetz Hämatologie / internistische Onkologie Praxis Troisdorf

    Troisdorf, North Rhine-Westphalia, 53840

  • Universitätsklinikum Tübingen Universitäts-Frauenklinik

    Tübingen, Baden-Wurttemberg, 72016

  • Universitätsfrauenklinik Ulm Frauenheilkunde und Geburtshilfe

    Ulm, Baden-Wurttemberg, 89075

  • Christliches Klinikum Unna gGmbH Brustzentrum

    Unna, North Rhine-Westphalia, 59423

  • Praxis für Hämatologie und internistische Onkologie Praxis Dr. Nusch

    Velbert, North Rhine-Westphalia, 42551

  • GRN Klinik Weinheim Gynäkologie

    Weinheim, Baden-Wurttemberg, 69469

  • St. Josefs-Hospital Wiesbaden Frauenklinik - Gynäkologie

    Wiesbaden, Hesse, 65189

  • Marien Hospital / Senologie Brustzentrum

    Witten, North Rhine-Westphalia, 58452

  • Helios Universitätsklinikum Frauenheilkunde & Geburtshilfe

    Wuppertal, North Rhine-Westphalia, 42283

  • Frauenklinik und Poliklinik / Studienzentrale Josef-Schneider-Straße 4

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

Official title: Adjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Endocrine Therapy Plus Ribociclib Versus Chemotherapy in Intermediate Risk, HR+/HER2- Early Breast Cancer

The study investigates, whether the patient group with intermediate-risk early breast cancer benefits from treatment with ribociclib in combination with endocrine therapy compared to standard-of-care chemotherapy (followed by adjuvant endocrine therapy).

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 very positive national and international feedback to the ADAPT concept as a whole.

The aim of this ADAPTcycle phase-III-trial is to investigate whether the intermediate-risk patient group identified during the screening phase derives additional benefit from treatment with ribociclib in combination with ET compared to chemotherapy (followed by adjuvant ET).

Being tested
Ribociclib 200Mg Oral Tablet
Keywords
early breast cancer, ADAPT, endocrine therapy, ribociclib, intermediate 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.

  • Ribociclib 200Mg Oral TabletDrug

    Also called Kisqali

    3 x 200 MG per os

Study groups in NCT04055493
Study groupRoleWhat they receive
Ribociclib plus ETExperimentalRibociclib 600mg / day over 26 cycles + endocrine treatment of physician´s choice
Receives: Drug: Ribociclib 200Mg Oral Tablet
Standard-of-care chemotherapyNo interventionStandard-of-care chemotherapy according to the clinical guidelines, e.g., of the Breast Committee of the German Gynecological Oncology Group (AGO), and regional prescribing information depending on patient's needs for 16-24 weeks,

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 ribociclib + ET vs. standard-of-care chemotherapy

    Measured: at end of study, on average 5 years after start of treatment

  2. distant disease-free survival (dDFS)

    distant disease-free survival (dDFS) in the ribociclib + ET-group to demonstrate survival rate >92%

    Measured: at end of study, on average 5 years after start of treatment

Secondary outcomes (7)

  1. overall survival (OS) 95 % CI

    95 %-confidence interval (CI) for OS in both arms

    Measured: at end of study, on average 5 years after start of treatment

  2. distant disease-free survival (dDFS) 95 % CI

    95 %-confidence interval (CI) for dDFS in both arms

    Measured: at end of study, on average 5 years after start of treatment

  3. QoL

    quality of life (QoL) and correlation to treatment-related symptoms measured by EQ-VAS and triggered symptom questionnaire,

    Measured: at end of study, on average 5 years after start of treatment

  4. treatment adherence

    treatment adherence measured by drug intake compared between treatment arms

    Measured: at end of study, on average 5 years after start of treatment

  5. pathological complete response (pCR)

    Pathological response rate (defined as ypT0/is/ypN0), as well as further definitions (ypT0/ypN0; ypT0/is/any ypN, near pCR (ypT1a/any ypN)), in neoadjuvant treated patients

    Measured: at end of study, on average 5 years after start of treatment

  6. clinical response rate

    clinical response rate (by palpation, ultrasound, and further methods) compared between treatment arms

    Measured: at end of study, on average 5 years after start of treatment

  7. rate of breast-conservation therapy

    prevalence of breast conservation therapy vs. mastectomy compared between treatment arms

    Measured: at end of study, on average 5 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 posted13 Aug 2019
  2. Study start2 Jul 2019
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (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 (neo)adjuvant, phase-III trial evaluating the efficacy and safety of ribociclib combined with endocrine therapy (ET) versus standard-of-care chemotherapy in early breast cancer (EBC) patients with molecular HR+/HER2- subtype.
Masking
None (open label)
Enrolment
1,684 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04055493
Sponsor's protocol ID
WSG-AM08 (ADAPTcycle)
Acronym
ADAPTcycle
Status last verified
Oct 2026
First submitted
22 Jul 2019
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The sponsor is committed to following high ethical standards for reporting study results, including the timely communication and publication of clinical trial results, whatever their outcome. The sponsor assures that the key design elements of this protocol will be posted on a publicly accessible database, e.g., www.clinicaltrials.gov, before study start. As part of its commitment to full transparency in publications, the sponsor supports the full disclosure of all funding sources for the study and publications, as well as any actual and potential conflicts of interest of financial and non-financial nature by all authors, including medical writing / editorial support, if applicable.

Publications

  • Klier K, Patel YJ, Schinkothe T, Harbeck N, Schmidt A. Corrected QT Interval (QTc) Diagnostic App for the Oncological Routine: Development Study. JMIR Cardio. 2023 Sep 11;7:e48096. doi: 10.2196/48096.

    PubMed 37695655

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ribociclib 200Mg Oral Tablet in people with Breast Cancer Female, run by Women's Cancer Study Group GmbH at 86 sites in Germany.

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 40 inclusion and 39 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in Germany. 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, on average 5 years after start of treatment). The study lists 2 primary outcomes in all. 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 NCT04055493, which also lists 1 linked publication.

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 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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