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Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

NCT ID: NCT05452213

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2026-10-31

Brief Summary

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This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.

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Detailed Description

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This is a prospective, multicenter, phase IV, one-arm, open-label clinical trial investigating patients treated with ribociclib and standard of care endocrine therapy for hormone receptor positive (HR+) / human epidermal growth factor receptor negative (HER2-) advanced breast cancer in the first therapy line. Patients eligible for this trial will receive on-label ribociclib according to Summary of Product Characteristics (SmPC) and as well as the specified inclusion/exclusion criteria.

The survival rates for progression-free survival (PFS) and overall survival (OS) at month 12 are the co-primary objectives. Quality of life and toxicity are secondary objectives. Additionally, there is a comprehensive biomarker discovery and validation program included into the study.

A total of 1000 patients are planned to be enrolled into this trial in 75 trial sites in Germany.

Biomarkers will be evaluated before, during and after treatment or at progression. A comprehensive biospecimens sampling will be done to enable translational research projects and evaluation of potential biomarkers within circulation tumor desoxyribonucleic acid (ctDNA), circulating tumor ribonucleic acid (ctRNA), formaldehyde-fixed paraffin-embedded tissue (FFPE) tissue, Serum, Plasma and circulating immune cells

Conditions

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Breast Cancer Breast Neoplasms Breast Neoplasm Female Breast Cancer Female HER2-negative Breast Cancer Hormone Receptor-positive Breast Cancer Advanced Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

One-arm, open-label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ribociclib

Group Type EXPERIMENTAL

Ribociclib

Intervention Type DRUG

All patients will receive ribociclib in combination with standard endocrine therapy according to the current SmPC and local in-house standard.

Ribociclib will be administered once daily for 21 consecutive days followed by 7 days off treatment (28-day cycle). The daily dose is 600 mg/day.

Ribociclib and standard of care endocrine treatment will be prescribed and administered according to investigator's discretion.

Interventions

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Ribociclib

All patients will receive ribociclib in combination with standard endocrine therapy according to the current SmPC and local in-house standard.

Ribociclib will be administered once daily for 21 consecutive days followed by 7 days off treatment (28-day cycle). The daily dose is 600 mg/day.

Ribociclib and standard of care endocrine treatment will be prescribed and administered according to investigator's discretion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Indication for treatment with ribociclib in combination with endocrine therapy in the locally advanced or 1st line metastatic therapy setting according to SmPC. (Previous treatment with cycline dependent kinase 4/6 (CDK4/6) inhibitors is allowed in the adjuvant setting)
2. Written informed consent prior to beginning of trial specific procedures
3. Subject must be female and aged ≥ 18 years on the day of signing informed consent
4. Locally advanced or metastatic breast cancer not amenable to curative treatment
5. Patient has HER2-negative breast cancer confirmed by local laboratory defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory
6. Histologically confirmed estrogen receptor (ER) positive and/ or progesterone receptor (PgR) positive breast cancer determined by core biopsy according to local in-house standard.
7. corrected QT (QTcF) interval \< 450 ms
8. Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory
9. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 h prior to study entry and be willing to use highly effective method of contraception for course of the trial through 21 days after the last dose of trial treatment.
10. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.

Exclusion Criteria

1. Concurrent participation in a study with an investigational agent/device or within 14 days of study entry or 5 half-lives of the respective investigational agent/device, whichever is longer
2. Patients who are not treated for advanced HR+, HER2- breast cancer in the first line therapy setting.
3. Patient not eligible for treatment with ribociclib according to SmPC or investigator's discretion
4. Patients who are pregnant or lactating.
5. Patients with existing or patients who are at significant risk of developing corrected QT interval (QTc) prolongation. This includes

* patients with long QT syndrome
* uncontrolled or significant cardiac disease, including recent myocardial infarction, congestive heart failure, unstable angina and bradyarrhythmia
* electrolyte abnormalities
6. Patients with known hypersensitivity to the active substance of ribociclib, soya, peanut or any other of the excipients of ribociclib.
7. Patients with active systemic infections (for example, bacterial infection requiring intravenous antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection requiring systemic therapy) or viral load (such as known human immunodeficiency virus positivity or with known active hepatitis B or C, for example, hepatitis B surface antigen positive).
8. Patients with serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (such as severe renal impairment, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in clinically significant diarrhea).
9. Patient who do not agree to collection of biospecimens samples (blood, stool, tissue)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AGO Breast Study Group e.V.

UNKNOWN

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Institut fuer Frauengesundheit

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter A. Fasching, MD, Prof.

Role: STUDY_CHAIR

Department of Gynecology and Obstetrics, Erlangen University Hospital

Tanja Fehm, MD, Prof.

Role: STUDY_CHAIR

Department of Gynecology/Obstetrics |University Hospital Düsseldorf, Germany

Andreas Schneeweiss, MD, Prof.

Role: STUDY_CHAIR

National Center for Tumor Diseases (NCT) | Heidelberg University Hospital and German Cancer Research Center

Locations

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Department of Gynecology and Obstetrics, Erlangen University Hospital

Erlangen, Bavaria, Germany

Site Status RECRUITING

Department of Gynecology and Obstetrics, University Medicine Mainz

Mainz, Hesse, Germany

Site Status RECRUITING

Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH

Bottrop, North Rhine-Westphalia, Germany

Site Status RECRUITING

Klinikum St Marien Amberg

Amberg, , Germany

Site Status RECRUITING

Onkologie Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg

Aschaffenburg, , Germany

Site Status RECRUITING

Klinik für Hämatologie und Onkologie, Uniklinik Augsburg

Augsburg, , Germany

Site Status NOT_YET_RECRUITING

University Hospital Augsburg

Augsburg, , Germany

Site Status RECRUITING

Frauenklinik des Klinikums Bamberg

Bamberg, , Germany

Site Status NOT_YET_RECRUITING

MediOnko GbR

Berlin, , Germany

Site Status NOT_YET_RECRUITING

HELIOS Klinikum Berlin-Buch

Berlin, , Germany

Site Status NOT_YET_RECRUITING

Zentrum für ambulante Hämatologie und Onkologie (ZAHO) an der Robert-Janker-Klinik

Bonn, , Germany

Site Status NOT_YET_RECRUITING

Klinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte

Bremen, , Germany

Site Status NOT_YET_RECRUITING

Klinikum Chemnitz gGmbH, Klinik für Frauenheilkunde und Geburtshilfe

Chemnitz, , Germany

Site Status NOT_YET_RECRUITING

Kliniken Der Stadt Köln gGmbH

Cologne, , Germany

Site Status RECRUITING

Carl-Thiem-Klinikum Cottbus

Cottbus, , Germany

Site Status RECRUITING

Staedtisches Klinikum Dessau, Gynecology and Obstetrics

Dessau, , Germany

Site Status RECRUITING

Universitäts-Frauenklinik Carl Gustav Carus Universität Dresden

Dresden, , Germany

Site Status NOT_YET_RECRUITING

Universitaetsklinikum Duesseldorf AöR

Düsseldorf, , Germany

Site Status RECRUITING

Universitaetsklinikum Essen AöR, Gynecology and Obstetrics

Essen, , Germany

Site Status NOT_YET_RECRUITING

Klinikum Esslingen GmbH

Esslingen am Neckar, , Germany

Site Status NOT_YET_RECRUITING

Agaplesion Frankfurter Diakonie Kliniken gGmbH, Gynecology and Obstetrics

Frankfurt am Main, , Germany

Site Status NOT_YET_RECRUITING

Universitäts-Frauenklinik Frankfurt

Frankfurt am Main, , Germany

Site Status NOT_YET_RECRUITING

Universitäts-Frauenklinik Freiburg

Freiburg im Breisgau, , Germany

Site Status NOT_YET_RECRUITING

Medizinisches Versorgungszentrum Onkologie Georgsmarienhütte und Bramsche

Georgsmarienhütte, , Germany

Site Status RECRUITING

Universitäts-Frauenklinik Hamburg-Eppendorf

Hamburg, , Germany

Site Status NOT_YET_RECRUITING

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, , Germany

Site Status NOT_YET_RECRUITING

Nationales Centrum für Tumorerkrankungen, Universitätsklinikum Heidelberg Abteilung für Gynäkologie und Geburtshilfe

Heidelberg, , Germany

Site Status RECRUITING

Frauenklinik, SLK-Kliniken Heilbronn GmbH

Heilbronn, , Germany

Site Status RECRUITING

Staedtisches Klinikum Karlsruhe gGmbH, Gynecology and Obstetrics

Karlsruhe, , Germany

Site Status RECRUITING

University Medical Centre Schleswig-Holstein, Gynecology and Obstetrics

Kiel, , Germany

Site Status RECRUITING

ZAGO-Zentrum für ambulante gynäkologische Onkologie

Krefeld, , Germany

Site Status RECRUITING

Klinikum Kulmbach

Kulmbach, , Germany

Site Status RECRUITING

VK&K Studienzentrum Landshut am Lakumed Klinikum Landshut-Achdorf

Landshut, , Germany

Site Status NOT_YET_RECRUITING

Praxis Dr. Müller MVM GmbH, Studienzentrum UnterEms

Leer, , Germany

Site Status NOT_YET_RECRUITING

Universitäts-Frauenklinik Leipzig

Leipzig, , Germany

Site Status NOT_YET_RECRUITING

Ev. Krankenhaus Bethesda Mönchengladbach

Mönchengladbach, , Germany

Site Status NOT_YET_RECRUITING

Hämatologie Onkologie Gemeinschaftspraxis Pasing

Munich, , Germany

Site Status RECRUITING

MVZ Nordhausen gGmbH

Nordhausen, , Germany

Site Status RECRUITING

Klinikum Nürnberg

Nuremberg, , Germany

Site Status NOT_YET_RECRUITING

Frauenklinik, Medius Klinik Nürtingen

Nürtingen, , Germany

Site Status RECRUITING

Gemeinschaftspraxis für Hämatologie und Onkologie GbR

Ravensburg, , Germany

Site Status RECRUITING

Frauenklinik, Diakoniekrankenhaus Rotenburg

Rotenburg (Wümme), , Germany

Site Status RECRUITING

Leopoldina Krankenhaus der Stadt Schweinfurt gGmbH

Schweinfurt, , Germany

Site Status RECRUITING

Schwerpunktpraxis für Hämatologie, Onkologie und Magen-Darm Diagnostik

Singen, , Germany

Site Status RECRUITING

Onkologische Schwerpunktpraxis Speyer

Speyer, , Germany

Site Status RECRUITING

Klinikum Stuttgart

Stuttgart, , Germany

Site Status NOT_YET_RECRUITING

Onkologie Rheinsieg, Praxisnetzwerk Hämatologie und internistische Onkologie

Troisdorf, , Germany

Site Status NOT_YET_RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Site Status RECRUITING

Universitäts-Frauenklinik Ulm

Ulm, , Germany

Site Status NOT_YET_RECRUITING

MVZ Nordoberpfalz

Weiden, , Germany

Site Status NOT_YET_RECRUITING

Medizinische Studiengesellschaft Nord-West GmbH

Westerstede, , Germany

Site Status RECRUITING

Rems-Murr Kliniken Winnenden

Winnenden, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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CAPTOR Study Manager

Role: CONTACT

[email protected]
09131 9278638

Facility Contacts

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Peter A Fasching, MD, Prof.

Role: primary

[email protected]
+49 9131 8543470

Marcus Schmidt, MD, Prof.

Role: primary

[email protected]
+49 6131 176884

Hans-Christian Kolberg, MD

Role: primary

[email protected]
+49 2041 1061601

Tanja H Haunzenberger, MD

Role: primary

[email protected]
+499621381381

Manfred Welslau, MD

Role: primary

[email protected]

Frank Jordan, MD

Role: primary

[email protected]

Nina Ditsch, MD, Prof.

Role: primary

[email protected]
+498214002208

Denise Wrobel, MD

Role: primary

[email protected]

Gülten Oskay-Özcelik, MD

Role: primary

[email protected]

Michael Untch, MD

Role: primary

[email protected]

Martin Esser, MD

Role: primary

[email protected]

Mustafa Aydogdu, MD

Role: primary

[email protected]

Petra Krabisch, MD

Role: primary

[email protected]

Myriam EM Vincent

Role: primary

[email protected]
+4922189076700

Nikola Bangemann, MD

Role: primary

[email protected]

Hermann Voß, MD

Role: primary

[email protected]
+493405014310

Pauline Wimberger, MD

Role: primary

[email protected]

Tanja Fehm, MD, Prof.

Role: primary

[email protected]
+492118117501

Oliver Hoffmann, MD

Role: primary

[email protected]
+492017232575

Alexander Hein, MD

Role: primary

[email protected]

Marc AM Thill, MD, Prof.

Role: primary

[email protected]
+496995332228

Christine Solbach, MD

Role: primary

[email protected]

Ingolf Juhasz-Böss, MD

Role: primary

[email protected]

Kerstin Lüdtke-Heckenkamp, MD

Role: primary

[email protected]

Volkmar Müller, MD

Role: primary

[email protected]

Christian Schem, MD

Role: primary

[email protected]

Andreas Schneeweiss, MD

Role: primary

[email protected]

Nikolaus De Gregorio, MD

Role: primary

[email protected]

Gariele Kaltenecker, MD

Role: primary

[email protected]
+4972197462406

Marion van Mackelenbergh, MD

Role: primary

[email protected]
+4943150021410

Gunther M Rogmans, MD

Role: primary

[email protected]
+492151322969

Benno Lex, MD

Role: primary

[email protected]
+499221981901

Ursula Vehling-Kaiser, MD

Role: primary

[email protected]

Lothar Müller, MD

Role: primary

[email protected]

Bahriye Aktas, MD

Role: primary

[email protected]

Iris Scheffen, MD

Role: primary

[email protected]

Matthias Zingerle, MD

Role: primary

[email protected]

Andrea Grafe, MD

Role: primary

[email protected]

Christine Zeder-Göß, MD

Role: primary

[email protected]
+499113983843

Elke Faust, MD

Role: primary

[email protected]

Thomas Decker, MD

Role: primary

[email protected]

Tobias Hesse, MD

Role: primary

[email protected]

Michael Weigel, MD

Role: primary

[email protected]

Thomas Fietz, MD

Role: primary

[email protected]

Gregor Bolz, MD

Role: primary

[email protected]

Ulrich Karck, MD

Role: primary

[email protected]

Ernst Rodermann, MD

Role: primary

[email protected]

Eva-Maria Grischke, MD, Prof.

Role: primary

[email protected]
+4970712982211

Brigitte Rack, MD

Role: primary

[email protected]

Robert Funck, MD

Role: primary

[email protected]

Jan Janssen, MD

Role: primary

Hans-Joachim Strittmatter, MD

Role: primary

[email protected]

Other Identifiers

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IFG-01-2022

Identifier Type: -

Identifier Source: org_study_id

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