Clinical trial • Phase III • Oncology

RIBOCICLIB for Hormone receptor positive HER2-negative early breast cancer

Phase III trial of RIBOCICLIB for Hormone receptor positive HER2-negative early breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Hormone receptor positive HER2-negative early breast cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
19-09-2024
First CTIS Authorization Date
01-10-2024

Trial design

Randomised, open-label, control arm: standard-of-care chemotherapy (e.g., according to regional prescribing information and clinical guidelines of the breast committee of the german gynecological oncology group (ago)) for 16-24 weeks; specific chemotherapy drug(s), dose and schedule are not specified. Phase III trial in Germany.

Randomised
Yes
Open Label
Yes
Comparator
Control arm: Standard-of-care chemotherapy (e.g., according to regional prescribing information and clinical guidelines of the Breast Committee of the German Gynecological Oncology Group (AGO)) for 16-24 weeks; specific chemotherapy drug(s), dose and schedule are not specified.
Biomarker Stratified
True, biomarkers: Ki-67 and Oncotype DX (proliferation/genomic risk parameters)
Target Sample Size
1684
Trial Duration For Participant
2555

Eligibility

Recruits 1684 Vulnerable population flag is selected. Participants are adult females (≥18). Written informed consent is required prior to any screening procedures. No specific assent procedures or minor consent arrangements are described..

Pregnancy Exclusion
Pregnant or nursing (lactating) woman.
Vulnerable Population
Vulnerable population flag is selected. Participants are adult females (≥18). Written informed consent is required prior to any screening procedures. No specific assent procedures or minor consent arrangements are described.

Inclusion criteria

  • {"criterion_text":"- Written informed consent prior to any screening procedures."}
  • {"criterion_text":"- Patient is classified as intermediate risk according to the ADAPT intermediate to high-risk definition (i) (as follows), or (only in case of missing Oncotype DX® data), according to the clinical intermediate-risk definition (ii) (as follows). (For detailed information see study protocol)"}
  • {"criterion_text":"- No contraindication for (neo)-adjuvant ET and/or chemotherapy"}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1."}
  • {"criterion_text":"- 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, haemoglobin ≥ 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."}
  • {"criterion_text":"- 12-lead-ECG with: QTcF interval at screening < 450 msec (using Fridericia’s correction), mean resting heart rate 50-90 bpm (determined from the ECG)."}
  • {"criterion_text":"- Ability to swallow ribociclib tablets or to administer other study medication, respectively."}
  • {"criterion_text":"- Ability to communicate with the investigator and comply with study procedures."}
  • {"criterion_text":"- Willing to remain during therapy at the clinical site, as required by the protocol."}
  • {"criterion_text":"- Female."}
  • {"criterion_text":"- ≥ 18 years of age."}
  • {"criterion_text":"- 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 oestradiol in the postmenopausal range per local normal range. 4b. OR: Pre-menopausal patients: confirmed negative serum or urine pregnancy test (β-hCG) before starting study treatment, or patient has had a hysterectomy."}
  • {"criterion_text":"- Histologically confirmed diagnosis of primary oestrogen-receptor positive and/or progesterone-receptor positive (≥ 1%) early breast cancer by local laboratory."}
  • {"criterion_text":"- 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 analysed tissue sample and all tested by a local laboratory)."}
  • {"criterion_text":"- 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. Radiotherapy may be performed in parallel or sequentially to either ribociclib or standard of care treatment, as per investigator´s decision."}
  • {"criterion_text":"- No evidence of distant metastasis (confirmed prior to randomization by CT thorax / abdomen, X-ray chest, ultrasound liver, bone scan, or PET-CT, respectively)."}
  • {"criterion_text":"- Patient has available tumour tissue from primary diagnostic biopsy."}

Exclusion criteria

  • {"criterion_text":"- Patient with distant metastases of breast cancer beyond regional lymph nodes."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Patient with a known hypersensitivity to any of the excipients of ribociclib, ET, or standard-of-care chemotherapy."}
  • {"criterion_text":"- Patient with inflammatory breast cancer at screening."}
  • {"criterion_text":"- Patient is concurrently using other anti-cancer therapy."}
  • {"criterion_text":"- Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects."}
  • {"criterion_text":"- Patient is currently receiving warfarin or other coumarin-derived anti-coagulant for treatment, prophylaxis, or otherwise."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Participation in another investigational study in which the patient´s IMP-treatment is not yet completed and up to 30 days after ending of IMP-treatment in this respective investigational study"}
  • {"criterion_text":"- Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤ 1."}
  • {"criterion_text":"- Not able to understand and to comply with study instructions and requirements."}
  • {"criterion_text":"- Pregnant or nursing (lactating) woman."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- Use of oral (oestrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy."}
  • {"criterion_text":"- Patient has a concurrent malignancy, or malignancy within 5 years prior to randomization, or known history of invasive breast cancer."}
  • {"criterion_text":"- 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, diarrhoea, malabsorption syndrome, or small-bowel resection)."}
  • {"criterion_text":"- Patient has a known history of HIV infection. Screening for HIV- infection and testing for HIV is highly recommended according to current valid (local) clinical guidelines, but neither part of the interventional study procedures, nor required for enrolment."}
  • {"criterion_text":"- Patient has known active hepatitis-B-virus (HBV) or hepatitis-C- virus (HCV) infection. Screening for HBV or HBC-infection and testing for hepatitis-B or -C is highly recommended according to current valid (local) clinical guidelines, but neither part of the interventional study procedures, nor required for enrollment."}
  • {"criterion_text":"- 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.)."}
  • {"criterion_text":"- 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, polymorphic ventricular tachycardia in patients with long QT syndrome) including uncorrected hypokalaemia 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., bi-fascicular block, Mobitz type II, and 3rd-degree AV block), systolic blood pressure (SBP) > 160 or < 90 mmHg."}
  • {"criterion_text":"- Patient has received prior (neo)-adjuvant treatment with chemotherapy, ET, or any CDK4/6 inhibitor for breast cancer."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- iDFS and dDFS","definition_or_measurement_approach":"Primary endpoints listed as iDFS (invasive disease-free survival) and dDFS (distant disease-free survival). The main objective references superiority in iDFS of ribociclib + ET vs chemotherapy and a 5-year dDFS rate target (>92%) for the ribociclib + ET group; no further endpoint definitions are provided in the CTIS record."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS) and dDFS,","definition_or_measurement_approach":"Overall survival (OS) and distant disease-free survival (dDFS) compared between arms; specific measurement definitions not provided in CTIS record."}
  • {"endpoint_text":"- quality of life (QoL)","definition_or_measurement_approach":"Quality of life measured; secondary objectives indicate QoL and correlation to treatment related symptoms measured by EQ-VAS and triggered symptom questionnaire."}
  • {"endpoint_text":"- treatment adherence (measured by drug intake),","definition_or_measurement_approach":"Treatment adherence explicitly described as measured by drug intake."}
  • {"endpoint_text":"- local and central Ki-67 values in all tissue samples.","definition_or_measurement_approach":"Comparison of Ki-67 values measured by local pathologists vs central pathologist in all tissue samples; no additional measurement details in CTIS record."}
  • {"endpoint_text":"- Pathological response rate (defined as ypT0/is/ypN0), as well as further definitions (ypT0/ypN0; ypT0/is/any ypN, near pCR (ypT1a/any ypN)),","definition_or_measurement_approach":"Pathological complete response (pCR) defined as ypT0/is/ypN0; additional response definitions listed in endpoint text."}
  • {"endpoint_text":"- Clinical response rate (by palpation, ultrasound, and further methods),","definition_or_measurement_approach":"Clinical response assessed by palpation, ultrasound and other methods; no detailed measurement schedule provided in CTIS record."}
  • {"endpoint_text":"- Rate of breast-conservation therapy","definition_or_measurement_approach":"Rate of breast-conservation surgery versus mastectomy by treatment arm; no further definition provided."}

Recruitment

Planned Sample Size
1684
Recruitment Window Months
113
Consent Approach
Written informed consent required prior to any screening procedures. Participants are adult females (≥18) who provide consent themselves. Subject information and informed consent form documents are listed in the CTIS documents. No mention of assent or separate minor consent procedures; languages available for consent documents are not specified.

Geography

Total Number Of Sites
85
Total Number Of Participants
1684

Germany

Earliest CTIS Part Ii Submission Date
24-09-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
504
Number Of Sites
85
Number Of Participants
1684

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Frauenklinik und Poliklinik
Contact Person Name
Achim Wöckel
Contact Person Email
direktion_ufk@ukw.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Tanja Fehm
Site Name
Marienhospital Bottrop gGmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Hans-Christian Kolberg
Contact Person Email
gynaekologie@mhb-bottrop.de
Site Name
Klinikum Ernst von Bergmann gGmbH
Department Name
Brustzentrum
Contact Person Name
Dorothea Fischer
Contact Person Email
frauenklinik@klinikumevb.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Beatrix Janke
Contact Person Email
beatrix.janke@slk-kliniken.de
Site Name
Carl-Thiem-Klinikum Cottbus gGmbH
Department Name
Frauenklinik
Contact Person Name
Nikola Bangemann
Contact Person Email
info@ctk.de
Site Name
Agaplesion Diakonieklinikum Hamburg gGmbH
Department Name
Brustzentrum
Contact Person Name
Celalettin Ugur
Contact Person Email
info.dkh@agaplesion.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Gynäkologie und Geburtsmedizin
Contact Person Name
Elmar Stickeler
Contact Person Email
gynaekologie@ukaachen.de
Site Name
St. Franziskus-Hospital GmbH
Department Name
MVZ MediaVita
Contact Person Name
Corina Neumann
Site Name
MVZ-Onkologie Velbert GbR
Department Name
MVZ-Onkologie Velbert GbR
Contact Person Name
Arnd Nusch
Contact Person Email
info@onkologie-velbert.de
Site Name
University Hospital Cologne AöR
Department Name
Brustkrebszentrum
Contact Person Name
Wolfram Malter
Site Name
St. Elisabeth Krankenhaus GmbH
Department Name
Brustzentrum - Senologie
Contact Person Name
Claudia Schumacher
Contact Person Email
info@hohenlind.de
Site Name
DRK Kliniken Berlin
Department Name
Brustzentrum Köpenick
Contact Person Name
Anke Kleine-Tebbe
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Frauenheilkunde und Geburtshilfe
Contact Person Name
Nadia Harbeck
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Frauenheilkunde
Contact Person Name
Beate Rautenberg
Site Name
St. Barbara-Klinik Hamm GmbH
Department Name
Brustzentrum
Contact Person Name
Claudia Strunk
Contact Person Email
cstrunk@barbaraklinik.de
Site Name
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Department Name
Brustzentrum Rhein-Ruhr
Contact Person Name
Oleg Gluz
Site Name
Klinikum Leverkusen gGmbH
Department Name
Brustkrebszentrum
Contact Person Name
Andrea Heider
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Frauenklinik
Contact Person Name
Andreas Hartkopf
Site Name
Klinikum Dortmund gGmbH
Department Name
Frauenklinik Dortmund
Contact Person Name
Claudia Biehl
Contact Person Email
claudia.biehl@klinikumdo.de
Site Name
Onkologische Schwerpunktpraxis Bielefeld
Department Name
Onkologische Schwerpunktpraxis Bielefeld
Contact Person Name
Siemke Steinke
Contact Person Email
studien@onkologie-bielefeld.de
Site Name
Johanniter GmbH
Department Name
Johanniter-Krankenhaus Stendal Gynäkologisches Krebszentrum
Contact Person Name
Sylvia Ruth
Site Name
Sana Klinikum Offenbach GmbH
Department Name
Onkologisches Centrum Offenbach, Brust- und Gynäkologisches Krebszentrum
Contact Person Name
Athansios Argyriadis
Contact Person Email
OCO-SOF@sana.de
Site Name
Katholisches Klinikum Koblenz Montabaur gGmbH
Department Name
Brustzentrum am Marienhof
Contact Person Name
Jan Dünnebacke
Contact Person Email
gynaekologie.kkm@bbtgruppe.de
Site Name
Klinikum Obergoeltzsch Rodewisch
Department Name
Frauenklinik / Brustzentrum
Contact Person Name
Stefanie Strobel
Site Name
Oncologianova GmbH Gesellschaft fuer Innovationen in der Onkologie
Department Name
Oncologianova GmbH Gesellschaft fuer Innovationen in der Onkologie
Contact Person Name
Till-Oliver Emde
Contact Person Email
info@onkologie-re.de
Site Name
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
Department Name
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
Contact Person Name
Matthias Zaiss
Contact Person Email
info@onkologie-freiburg.de
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Innere Medizin 1
Contact Person Name
Sebastian Jud
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Frauenklinik - Brustzentrum
Contact Person Name
Jens-Uwe Blohmer
Contact Person Email
brustzentrum@charite.de
Site Name
Diakonie in Suedwestfalen gGmbH
Department Name
Diakonie Klinikum Jung-Stilling Gynäkologie und gynäkologische Onkologie
Contact Person Name
Marco Johannes Battista
Site Name
Klinikum Bremerhaven-Reinkenheide gGmbH
Department Name
Brustzentrum
Contact Person Name
Amelie Bletscher
Site Name
Marien-Hospital Witten
Department Name
Brustzentrum
Contact Person Name
Monika Graeser
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Landesfrauenklinik - Brustzentrum
Contact Person Name
Vesna Bjelic-Radisic
Site Name
DIAKOVERE Krankenhaus gGmbH
Department Name
Henriettenstift Frauenklinik
Contact Person Name
Kristina Lübbe
Contact Person Email
info@diakovere.de
Site Name
Klinikum Kassel GmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Gabriele Feisel-Schwickardi
Contact Person Email
info@klinikum-kassel.de
Site Name
Onkodok GmbH
Department Name
Onkologische Gemeinschaftspraxis
Contact Person Name
Reinhard Depenbusch
Site Name
Klinikverbund Suedwest GmbH
Department Name
Interdisziplinäres Brustzentrum Böblingen
Contact Person Name
Grischa Wachsmann
Site Name
Klinik Dr. Hancken GmbH
Department Name
Klinik Dr. Hancken Stade
Contact Person Name
Wiebke Timm
Contact Person Email
info@hancken.de
Site Name
Mammazentrum Hamburg MVZ GbR
Department Name
Mammazentrum Hamburg MVZ GbR
Contact Person Name
Christian Schem
Contact Person Email
info@mammazentrum-hamburg.de
Site Name
Stiftung Katholisches Marienhospital Aachen
Department Name
BrustCentrum Aachen
Contact Person Name
Esther Geller
Contact Person Email
brustcentrum@marienhospital.de
Site Name
Christliches Klinikum Unna gGmbH
Department Name
Gynäkologie und Geburtshilfe
Contact Person Name
Cosmin-Paul Sarac
Site Name
Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital Goch
Department Name
Klinik für Innere Medizin - Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Volker Runde
Contact Person Email
onkoambulanz@kkle.de
Site Name
MVZ Medical Center Duesseldorf GmbH
Department Name
GynOnco Düsseldorf
Contact Person Name
Athina Kostara
Contact Person Email
info@gynonco.de
Site Name
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Claudia Hänle
Site Name
Suedharz Klinikum Nordhausen gGmbH
Department Name
MVZ Nordhausen
Contact Person Name
Andrea Grafe
Contact Person Email
info@mvz-nordhausen.de
Site Name
Frauenaerztliche Gemeinschaftspraxis Casparistrasse
Department Name
Studien GbR Braunschweig
Contact Person Name
Ralf Lorenz
Site Name
Praxisnetz Hämatologie / internistische Onkologie
Department Name
Praxisnetz Hämatologie / internistische Onkologie
Contact Person Name
Ernst Rodermann
Contact Person Email
info@onkologie-rheinsieg.de
Site Name
Rotkreuzklinikum Muenchen gGmbH
Department Name
Interdisziplinbäres Brustzentrum
Contact Person Name
Michael Braun
Contact Person Email
kontakt@gynonko.de
Site Name
Klinikum St. Georg gGmbH
Department Name
Gynäkologie und Geburtshilfe
Contact Person Name
Uwe Köhler
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Gynäkologie
Contact Person Name
Lisa Steinhilper
Contact Person Email
frauenklinik@uke.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Brustzentrum
Contact Person Name
Joke Tio
Contact Person Email
brustzentrum@ukmuenster.de
Site Name
Praxis Dr. B. Adhami
Department Name
Praxis Dr. B. Adhami
Contact Person Name
Barmak Adhami
Contact Person Email
adhami@praxis-adhami.de
Site Name
Marien Gesellschaft Siegen gGmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe Brustzentrum Siegen-Olpe
Contact Person Name
Kristin Baumann
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Universitätsklinik und Poliklinik für Gynäkologie
Contact Person Name
Susanne Barrot
Contact Person Email
gyn@uk-halle.de
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Frauenheilkunde und Geburtshilfe Brustzentrum
Contact Person Name
Tjoung-Won Park-Simon
Contact Person Email
brustzentrum@mh-hannover.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Interdisziplinäres Brustzentrum
Contact Person Name
Stefanie Schütze
Contact Person Email
brustzentrum@med.uni-jena.de
Site Name
Klinikum Frankfurt Hoechst GmbH
Department Name
Klinik für Gynäkologie
Contact Person Name
Joachim Rom
Contact Person Email
frauenklinik-kfh@varisano.de
Site Name
Klinikum Mittelbaden Balg
Department Name
Brustzentrum Baden-Baden Balg
Contact Person Name
Antje Hahn
Site Name
Staedtisches Klinikum Lueneburg gGmbH
Department Name
Brustkrebszentrum Lüneburg
Contact Person Name
Peter Dall
Contact Person Email
info@klinikum-lueneburg.de
Site Name
Altmark-Klinikum gGmbH
Department Name
Brustzentrum Altmark
Contact Person Name
Susanne Kraudelt
Site Name
Haematologische Onkologische Praxis im Medicum
Department Name
Haematologische Onkologische Praxis im Medicum
Contact Person Name
Carsten Schreiber
Site Name
GRN Gesundheitszentren Rhein-Neckar gGmbH
Department Name
Brustzentrum Weinheim
Contact Person Name
Lelia Bauer
Contact Person Email
gynaekologie-weinheim@grn.de
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Gynäkologie
Contact Person Name
Marc Thill
Contact Person Email
brustzentrum.fdk@agaplesion.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe (Gynäkologie
Contact Person Name
Marika Henriette Princk
Site Name
DRK Krankenhaus Saarlouis
Department Name
Zertifiziertes Brustkrebszentrum Saarlouis
Contact Person Name
Johannes Bettscheider
Site Name
Evangelisches Krankenhaus Bergisch Gladbach gGmbH
Department Name
Brustzentrum, Frauenklinik
Contact Person Name
Lena Leitzen
Contact Person Email
brustzentrum@evk.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Brustzentrum
Contact Person Name
Pauline Wimberger
Site Name
MKS St. Paulus GmbH
Department Name
Märkisches Brustzentrum
Contact Person Name
Asja Sborowski
Contact Person Email
brustzentrum@marien-kh.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Vivantes Klinikum am Urban, Brustzentrum
Contact Person Name
Claudia Gerber-Schäfer
Contact Person Email
brustzentrum.kau@vivantes.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde
Contact Person Name
Bahriye Aktas
Contact Person Email
presse@uniklinik-leipzig.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Frauenklinik/Brustzentrum
Contact Person Name
Paul Gaß
Contact Person Email
brustzentrumchemnitz@skc.de
Site Name
Klinikum Suedstadt Rostock
Department Name
Frauenklinik
Contact Person Name
Toralf Reimer
Contact Person Email
ufk@kliniksued-rostock.de
Site Name
Evangelisches Waldkrankenhaus Spandau Krankenhausbetriebs gGmbH
Department Name
Brustzentrum
Contact Person Name
Silke Polata
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Frauenheilkunde, Geburtshilfe
Contact Person Name
Angelina Fink
Site Name
Schwerpunktpraxis der Gynäkologie und Onkologie
Department Name
Schwerpunktpraxis der Gynäkologie und Onkologie
Contact Person Name
Georg Heinrich
Contact Person Email
g.heinrich@bngo.de
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Brustzentrum Holweide
Contact Person Name
Vincent Myriam
Contact Person Email
brustzentrum@kliniken-koeln.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Oliver Hoffmann
Contact Person Email
brustzentrum@uk-essen.de
Site Name
Evangelische Kliniken Gelsenkirchen GmbH
Department Name
Klinik für Gynäkologie
Contact Person Name
Hans Holger Fischer
Contact Person Email
frauenklinik@evk-ge.de
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
Contact Person Name
Erich-Franz Solomayer
Contact Person Email
frauenklinik.direktion@uks.eu
Site Name
Sankt Gertrauden-Krankenhaus GmbH
Department Name
Praxis für gynäkologische Onkologie im Brustzentrum City am Sankt Gertrauden Krankenhaus
Contact Person Name
Lidia Perlova-Griff
Site Name
Franziskus Hospital Harderberg
Department Name
MVZ II der Niels Stensen Kliniken - Onkologie u. Hämatologie
Contact Person Name
Kerstin Luedtke-Heckenkamp
Contact Person Email
onkologie@nsk.de
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Klinik für Senologie/Brustzentrum
Contact Person Name
Sherko Kümmel
Contact Person Email
brustzentrum@kem-med.com
Site Name
Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz
Department Name
Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz
Contact Person Name
Christoph Uleer
Contact Person Email
info@frauenarzt-hildesheim.de
Site Name
St. Josefs-Hospital Wiesbaden GmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Antje Lehnert
Contact Person Email
brustzentrum@joho.de
Site Name
St.-Antonius-Hospital gGmbH
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Peter Staib

Sponsor

Primary sponsor

Full Name
WSG Westdeutsche Studiengruppe GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
X-act Cologne Clinical Research GmbH
Responsibilities
sponsorDuties codes 10, 6

Third parties

  • {"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"Biological sample analyses","organisation_type":"Educational Institution"}
  • {"country":"Germany","full_name":"X-act Cologne Clinical Research GmbH","duties_or_roles":"sponsorDuties codes 10, 6","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"CANKADO Service GmbH","duties_or_roles":"sponsorDuties code 7","organisation_type":"Health care"}
  • {"country":"Germany","full_name":"Universitätsklinikum Bonn, Studienzentrum Bonn","duties_or_roles":"sponsorDuties code 8","organisation_type":"Health care"}
  • {"country":"Germany","full_name":"Universitätsklinikum Düsseldorf AöR, Forschungslabore der Frauenklinik","duties_or_roles":"sponsorDuties code 4","organisation_type":"Health care"}
  • {"country":"Germany","full_name":"Hannover Unified Biobank","duties_or_roles":"Storage biological samples (sponsorDuties code 15)","organisation_type":"Health care"}

Investigational products

Investigational Product Name
Kisqali 200 mg film-coated tablets
Active Substance
RIBOCICLIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Marketing authorisation EU/1/17/1221/005 (MA holder: NOVARTIS EUROPHARM LIMITED)
Maximum Dose
600 mg
Combination Treatment
Yes

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