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

NCT05452213 | Recruiting Phase 4

• 1 other identifier: IFG-01-2022
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 52

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 12-month PFS rate

  The rate for progression-free survival at month 12 will be calculated.

  12 months

• 12-month OS rate

  The rate for overall survival at month 12 will be calculated.

  12 months

Secondary Outcomes (9)

• 24-month PFS rate

  24 months

• 24-month OS rate

  24 months

• 36-month PFS rate

  36 months

• 36-month OS rate

  36 months

• Median progression-free survival

  From date of enrollment until first documented progression or date of death from any cause or regular end of study (up to 24 months) whichever is first.

Other Outcomes (20)

• Correlation of genome wide genetic biomarkers with progression-free survival

  Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.

• Correlation of genome wide genetic biomarkers with overall survival

  Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.

• Correlation of genome wide genetic biomarkers with quality of life

  Measured from biomaterial collected at baseline, 2 weeks, 3 months, 6 months, 12 months, 18 months or at the end of treatment in case treatment is stopped irregularly.

Study Arms (1)

Ribociclib

EXPERIMENTAL

Drug: Ribociclib

Interventions

Ribociclib 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.

Ribociclib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Written informed consent prior to beginning of trial specific procedures
• Subject must be female and aged ≥ 18 years on the day of signing informed consent
• Locally advanced or metastatic breast cancer not amenable to curative treatment
• 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
• Histologically confirmed estrogen receptor (ER) positive and/ or progesterone receptor (PgR) positive breast cancer determined by core biopsy according to local in-house standard.
• corrected QT (QTcF) interval \< 450 ms
• Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory
• 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.
• Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.

You may not qualify if:

• 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
• Patients who are not treated for advanced HR+, HER2- breast cancer in the first line therapy setting.
• Patient not eligible for treatment with ribociclib according to SmPC or investigator's discretion
• Patients who are pregnant or lactating.
• 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
• Patients with known hypersensitivity to the active substance of ribociclib, soya, peanut or any other of the excipients of ribociclib.
• 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).
• 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).
• Patient who do not agree to collection of biospecimens samples (blood, stool, tissue)

Sponsors & Collaborators

• Institut fuer Frauengesundheit: lead
• AGO Breast Study Group e.V.: collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (52)

Department of Gynecology and Obstetrics, Erlangen University Hospital

Erlangen, Bavaria, 91054, Germany

RECRUITING

Department of Gynecology and Obstetrics, University Medicine Mainz

Mainz, Hesse, 55131, Germany

RECRUITING

Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH

Bottrop, North Rhine-Westphalia, 46236, Germany

RECRUITING

Klinikum St Marien Amberg

Amberg, 92224, Germany

RECRUITING

Onkologie Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg

Aschaffenburg, 63739, Germany

RECRUITING

Klinik für Hämatologie und Onkologie, Uniklinik Augsburg

Augsburg, 86156, Germany

NOT YET RECRUITING

University Hospital Augsburg

Augsburg, 86156, Germany

RECRUITING

Frauenklinik des Klinikums Bamberg

Bamberg, 96049, Germany

NOT YET RECRUITING

MediOnko GbR

Berlin, 10367, Germany

NOT YET RECRUITING

HELIOS Klinikum Berlin-Buch

Berlin, 13125, Germany

NOT YET RECRUITING

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

Bonn, 53129, Germany

NOT YET RECRUITING

Klinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte

Bremen, 28205, Germany

NOT YET RECRUITING

Klinikum Chemnitz gGmbH, Klinik für Frauenheilkunde und Geburtshilfe

Chemnitz, 09116, Germany

NOT YET RECRUITING

Kliniken Der Stadt Köln gGmbH

Cologne, 51067, Germany

RECRUITING

Carl-Thiem-Klinikum Cottbus

Cottbus, 03048, Germany

RECRUITING

Staedtisches Klinikum Dessau, Gynecology and Obstetrics

Dessau, 06847, Germany

RECRUITING

Universitäts-Frauenklinik Carl Gustav Carus Universität Dresden

Dresden, 01307, Germany

NOT YET RECRUITING

Universitaetsklinikum Duesseldorf AöR

Düsseldorf, 40225, Germany

RECRUITING

Universitaetsklinikum Essen AöR, Gynecology and Obstetrics

Essen, 45147, Germany

NOT YET RECRUITING

Klinikum Esslingen GmbH

Esslingen am Neckar, 73730, Germany

NOT YET RECRUITING

Agaplesion Frankfurter Diakonie Kliniken gGmbH, Gynecology and Obstetrics

Frankfurt am Main, 60431, Germany

NOT YET RECRUITING

Universitäts-Frauenklinik Frankfurt

Frankfurt am Main, 60596, Germany

NOT YET RECRUITING

Universitäts-Frauenklinik Freiburg

Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

Medizinisches Versorgungszentrum Onkologie Georgsmarienhütte und Bramsche

Georgsmarienhütte, 49124, Germany

RECRUITING

Universitäts-Frauenklinik Hamburg-Eppendorf

Hamburg, 20246, Germany

NOT YET RECRUITING

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, 20357, Germany

NOT YET RECRUITING

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

Heidelberg, 69120, Germany

RECRUITING

Frauenklinik, SLK-Kliniken Heilbronn GmbH

Heilbronn, 74078, Germany

RECRUITING

Staedtisches Klinikum Karlsruhe gGmbH, Gynecology and Obstetrics

Karlsruhe, 76133, Germany

RECRUITING

University Medical Centre Schleswig-Holstein, Gynecology and Obstetrics

Kiel, 24105, Germany

RECRUITING

ZAGO-Zentrum für ambulante gynäkologische Onkologie

Krefeld, 47805, Germany

RECRUITING

Klinikum Kulmbach

Kulmbach, 95326, Germany

RECRUITING

VK&K Studienzentrum Landshut am Lakumed Klinikum Landshut-Achdorf

Landshut, 84036, Germany

NOT YET RECRUITING

Praxis Dr. Müller MVM GmbH, Studienzentrum UnterEms

Leer, 26789, Germany

NOT YET RECRUITING

Universitäts-Frauenklinik Leipzig

Leipzig, 04103, Germany

NOT YET RECRUITING

Ev. Krankenhaus Bethesda Mönchengladbach

Mönchengladbach, 41061, Germany

NOT YET RECRUITING

Hämatologie Onkologie Gemeinschaftspraxis Pasing

Munich, 81241, Germany

RECRUITING

MVZ Nordhausen gGmbH

Nordhausen, 99734, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, 90419, Germany

NOT YET RECRUITING

Frauenklinik, Medius Klinik Nürtingen

Nürtingen, 72622, Germany

RECRUITING

Gemeinschaftspraxis für Hämatologie und Onkologie GbR

Ravensburg, 88212, Germany

RECRUITING

Frauenklinik, Diakoniekrankenhaus Rotenburg

Rotenburg (Wümme), 27356, Germany

RECRUITING

Leopoldina Krankenhaus der Stadt Schweinfurt gGmbH

Schweinfurt, 97422, Germany

RECRUITING

Schwerpunktpraxis für Hämatologie, Onkologie und Magen-Darm Diagnostik

Singen, 78224, Germany

RECRUITING

Onkologische Schwerpunktpraxis Speyer

Speyer, 61346, Germany

RECRUITING

Klinikum Stuttgart

Stuttgart, 70174, Germany

NOT YET RECRUITING

Onkologie Rheinsieg, Praxisnetzwerk Hämatologie und internistische Onkologie

Troisdorf, 53840, Germany

NOT YET RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

RECRUITING

Universitäts-Frauenklinik Ulm

Ulm, 89075, Germany

NOT YET RECRUITING

MVZ Nordoberpfalz

Weiden, 92637, Germany

NOT YET RECRUITING

Medizinische Studiengesellschaft Nord-West GmbH

Westerstede, 26655, Germany

RECRUITING

Rems-Murr Kliniken Winnenden

Winnenden, 71364, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter A. Fasching, MD, Prof.

  Department of Gynecology and Obstetrics, Erlangen University Hospital

  STUDY CHAIR

• Tanja Fehm, MD, Prof.

  Department of Gynecology/Obstetrics |University Hospital Düsseldorf, Germany

  STUDY CHAIR

• Andreas Schneeweiss, MD, Prof.

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

  STUDY CHAIR

Central Study Contacts

CAPTOR Study Manager

CONTACT

09131 9278638; captor@ifg-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One-arm, open-label

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 11, 2022
• Study Start: October 12, 2022
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (52)