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. 1363 participants.

Overview

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

Key dates

Initial CTIS Submission Date
21-03-2025
First CTIS Authorization Date
11-06-2025

Trial design

Phase III trial in Germany, Portugal.

Target Sample Size
1363
Trial Duration For Participant
1095

Eligibility

Recruits 1363 Vulnerable population selected. Participants are adults (≥18 years). Informed consent is required using the Main ICF (Adult) and associated ICF procedure documents. ICF-related documents are available in German and Portuguese (and an ICF procedure in English). No assent process for minors is indicated..

Pregnancy Exclusion
Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
Vulnerable Population
Vulnerable population selected. Participants are adults (≥18 years). Informed consent is required using the Main ICF (Adult) and associated ICF procedure documents. ICF-related documents are available in German and Portuguese (and an ICF procedure in English). No assent process for minors is indicated.

Inclusion criteria

  • {"criterion_text":"- Participant is an adult, male or female ≥ 18 years of age at the time of informed consent signature (ICF)."}
  • {"criterion_text":"- Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample and all tested by a local laboratory prior to enrolment."}
  • {"criterion_text":"- Participant has HER2− BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample."}
  • {"criterion_text":"- Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrolment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy. For participants with prior ET treatment >12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrolment. The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants."}
  • {"criterion_text":"- Participant has no contraindication to receive adjuvant ET in the study."}
  • {"criterion_text":"- Participant after surgical resection where tumour was removed completely, with the final surgical specimen microscopic margins free from tumour, and belongs to one of the following categories: anatomic stage group III and substets of anatomic stage group II."}
  • {"criterion_text":"- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1 or 2."}
  • {"criterion_text":"- Participant has adequate bone marrow and organ function."}
  • {"criterion_text":"- ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as: •\tQTcF interval at screening < 450 msec (QT interval using Fridericia’s correction). •\tMean resting heart rate 50-99 beats per minute (determined from the ECG )."}

Exclusion criteria

  • {"criterion_text":"- Participant with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery."}
  • {"criterion_text":"- Participant is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET."}
  • {"criterion_text":"- Participant has any other concurrent severe and/or uncontrolled medical condition"}
  • {"criterion_text":"- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality"}
  • {"criterion_text":"- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial."}
  • {"criterion_text":"- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- iBCFS using STEEP Version 2.0 criteria (Standardized Definitions for Efficacy Endpoints in Adjuvant Breast Cancer Clinical Trials), as assessed by Investigator","definition_or_measurement_approach":"Using STEEP Version 2.0 criteria, assessment by Investigator"}

Secondary endpoints

  • {"endpoint_text":"- Incidence and severity of adverse events (AEs) using CTCAE v4.03","definition_or_measurement_approach":"Adverse events graded and reported using CTCAE version 4.03"}
  • {"endpoint_text":"- iDFS utilisant les critères STEEP version 2.0","definition_or_measurement_approach":"iDFS evaluated using STEEP Version 2.0 criteria"}
  • {"endpoint_text":"- DRFS using STEEP Version 2.0 criteria","definition_or_measurement_approach":"Distant Relapse-Free Survival evaluated using STEEP Version 2.0 criteria"}
  • {"endpoint_text":"- RFI using STEEP Version 2.0 criteria","definition_or_measurement_approach":"Recurrence-Free Interval evaluated using STEEP Version 2.0 criteria"}
  • {"endpoint_text":"- Relative Dose Intensity (RDI)","definition_or_measurement_approach":"Relative dose intensity calculated as per protocol (no further definition provided in source)"}
  • {"endpoint_text":"- Overall survival (OS) defined as from the start of treatment to date of death due to any cause.","definition_or_measurement_approach":"Overall Survival defined as time from start of treatment to date of death due to any cause"}
  • {"endpoint_text":"- Time to discontinuation (TTD) of ribociclib","definition_or_measurement_approach":"Time from treatment start to discontinuation of ribociclib (no further detail provided)"}
  • {"endpoint_text":"- Changes from Baseline in FACT-B, FACT-ES, FACIT-F, EQ-5D-5L and WPAI-GH PRO questionnaires","definition_or_measurement_approach":"Change from baseline in listed patient-reported outcome questionnaires"}
  • {"endpoint_text":"- DDFS using STEEP Version 2.0 criteria","definition_or_measurement_approach":"Distant Disease-Free Survival evaluated using STEEP Version 2.0 criteria"}

Recruitment

Planned Sample Size
1363
Recruitment Window Months
74
Consent Approach
Informed consent required from adult participants using the Main ICF (Adult). ICF procedure documents are provided (L2_ICF Procedure). Main ICF documents available in German and Portuguese; ICF procedure available in English. No assent process for minors is indicated.

Geography

Total Number Of Sites
36
Total Number Of Participants
172

Germany

Earliest CTIS Part Ii Submission Date
03-06-2025
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
239
Number Of Sites
30
Number Of Participants
130

Sites

Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
#3139: Vivantes Brustzentrum
Contact Person Name
Claudia Gerber-Schäfer
Site Name
Marienhaus Klinikum Mainz GmbH
Department Name
#3141: Frauenklinik
Contact Person Name
Arnd Hoenig
Contact Person Email
a-hoenig@kkmainz.de
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
#3123: Geburtshilfe und Gynäkologie
Contact Person Name
Michael Untch
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
#3116: Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Marion Van Mackelenbergh
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
#3150: Abteilung für Gynäkologie
Contact Person Name
Volkmar Müller
Contact Person Email
v.mueller@uke.de
Site Name
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Department Name
#3104: Brustzentrum / Senologie
Contact Person Name
Iris Scheffen
Site Name
Haematologie-Onkologie im Zentrum MVZ GmbH
Department Name
#3131: Haematologie-Onkologie im Zentrum MVZ GmbH
Contact Person Name
Bernhard Heinrich
Site Name
Universitaetsklinikum Augsburg
Department Name
#3144: Klinik für Frauenheilkunde und Geburtsmedizin
Contact Person Name
Nina Ditsch
Contact Person Email
Nina.Ditsch@uk-augsburg.de
Site Name
Frauenaerzte am Bahnhofsplatz
Department Name
#3143 : Praxisgemeinschaft Frauenaerzte am Bahnhofsplatz
Contact Person Name
Christoph Uleer
Contact Person Email
C.Uleer@gmx.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
#3120: Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Nadia Harbeck
Site Name
Evangelisches Krankenhaus Bergisch Gladbach gGmbH
Department Name
#3111: Brustzentrum
Contact Person Name
Christian Rudlowski
Contact Person Email
c.rudlowski@evk.de
Site Name
ST. ELISABETH-KRANKENHAUS LEIPZIG gGmbH des Katholischen Kirchenlehens St. Trinitatis
Department Name
#3119: Senologie, Brustzentrum
Contact Person Name
Dagmar Langanke
Contact Person Email
dagmar.langanke@ek-leipzig.de
Site Name
MVZ Onkologie Velbert GbR
Department Name
#3102: MVZ für Haematologie
Contact Person Name
Arnd Nusch
Contact Person Email
nusch@aol.com
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
#3124: Klinik für Senologie/Brustzentrum
Contact Person Name
Simona Gipe
Contact Person Email
s.gipe@kem-med.com
Site Name
Marienhospital Bottrop gGmbH
Department Name
#3110: Klinik für Gynäkologie und Geburtshilfe, Brust und Gynäkologisches Krebszentrum
Contact Person Name
Hans-Christian Kolberg
Site Name
Technische Universitat Dresden
Department Name
#3126: Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Pauline Wimberger
Site Name
Luebecker Onkologische Schwerpunktpraxis
Department Name
#3133 : Luebecker Onkologische Schwerpunktpraxis
Contact Person Name
Jens Kisro
Contact Person Email
jens.kisro@t-online.de
Site Name
Onkologische Schwerpunktpraxis
Department Name
#3128: Onkologische Schwerpunktpraxis
Contact Person Name
Siemke Steinke
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
#3106: Klinik für Frauenheilkunde u. Geburtshilfe
Contact Person Name
Stephan Seitz
Contact Person Email
sseitz@csj.de
Site Name
Klinikverbund Suedwest GmbH
Department Name
#3142: Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Grischa Wachsmann
Site Name
Medical Center - University Of Freiburg
Department Name
#3136: Klinik für Frauenheilkunde
Contact Person Name
Beate Rautenberg
Site Name
Universitaetsklinikum Essen AöR
Department Name
#3107: Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Oliver Hoffmann
Contact Person Email
Oliver.hoffmann@uk-essen.de
Site Name
St. Vincenz-Krankenhaus GmbH
Department Name
#3127: Frauen- und Kinderklinik St. Louise
Contact Person Name
Michael Patrick Lux
Contact Person Email
M.Lux@vincenz.de
Site Name
Staedtisches Klinikum Dessau
Department Name
#3101: Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Hermann Voss
Site Name
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
Department Name
#3108: Gemeinschaftspraxis Für Hämatologie und Onkologie
Contact Person Name
Andreas Köhler
Contact Person Email
dr.koehler@onkologie-langen.de
Site Name
MVZ Nordoberpfalz GmbH
Department Name
#3103: Onkologie
Contact Person Name
Thomas Schichtl
Contact Person Email
thomas.schichtl@mvz-weiden.de
Site Name
MVZ fuer Haematologie und Onkologie Ravensburg GmbH
Department Name
#3115: Studienzentrum Onkologie Ravensburg
Contact Person Name
Thomas Decker
Contact Person Email
thomas.decker@onkonet.eu
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
#3138: Frauenklinik
Contact Person Name
Eugen Ruckhäberle
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
#3105: Frauenklinik mit Poliklinik
Contact Person Name
Peter Fasching
Site Name
Rotkreuzklinikum Muenchen gGmbH
Department Name
#3153: Frauenklinik
Contact Person Name
Anne Andrulat
Contact Person Email
anne.andrulat@swmbrk.de

Portugal

Earliest CTIS Part Ii Submission Date
15-05-2025
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
263
Number Of Sites
6
Number Of Participants
42

Sites

Site Name
Instituto Portugues De Oncologia Coimbra Francisco Gentil E.P.E.
Department Name
3403:Serviço de Oncologia Médica
Contact Person Name
Isabel Pazos
Contact Person Email
3217@ipocoimbra.min-saude.pt
Site Name
Hospital CUF Porto S.A.
Department Name
3404:Serviço de Oncologia
Contact Person Name
Claudia Caeiro
Contact Person Email
ensaiosclinicos@cuf.pt
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
3405:Serviço de Oncologia Médica
Contact Person Name
Ana Carmo Valente
Site Name
Champalimaud Clinical Centre
Department Name
3400:Unidade da Mama
Contact Person Name
Leonor Matos
Site Name
Hospital De Santa Maria E.P.E.
Department Name
3402:Serviço de Oncologia Médica
Contact Person Name
Leonor Ribeiro
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
3401:Serviço de Oncologia Médica
Contact Person Name
Ana Ferreira

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Iqvia Rds Inc.
Responsibilities
PRO management, including data collection; sponsor duty codes: 3
Name
Icon Clinical Research Limited
Responsibilities
Sponsor duties code: 1
Name
Parexel International (IRL) Limited
Responsibilities
Sponsor duties code: 12
Name
IQVIA Limited
Responsibilities
Sponsor duties include ECG mobile device/Alive Cor (code 15) and code 4 responsibilities

Third parties

  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Sponsor duties include: PRO management, including data collection; additional duty codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties codes: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Sponsor duties codes: 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties codes include: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited (Reading address)","duties_or_roles":"Sponsor duties include: ECG mobile device/Alive Cor (code 15)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RIBOCICLIB
Active Substance
RIBOCICLIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
2
Maximum Dose
400 mg (max daily dose amount 400 mg)
Investigational Product Name
LEUPRORELIN ACETATE
Active Substance
LEUPRORELIN ACETATE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
2
Maximum Dose
11.25 mg (max daily dose amount 11.25 mg)
Investigational Product Name
ANASTROZOLE
Active Substance
ANASTROZOLE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
2
Maximum Dose
1 mg (max daily dose amount 1 mg)
Investigational Product Name
GOSERELIN
Active Substance
GOSERELIN
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
2
Maximum Dose
10.8 mg (max daily dose amount 10.8 mg)
Investigational Product Name
LETROZOLE
Active Substance
LETROZOLE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
2
Maximum Dose
2.5 mg (max daily dose amount 2.5 mg)
Investigational Product Name
EXEMESTANE
Active Substance
EXEMESTANE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
2
Maximum Dose
25 mg (max daily dose amount 25 mg)
Combination Treatment
Yes

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