Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients (CAPTOR-BC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Neoplasms; Advanced Breast Cancer; Breast Neoplasm Female; Breast Cancer Female; HER2-negative Breast Cancer; Hormone Receptor-positive Breast Cancer
• Intervention / Treatment: Drug: Ribociclib

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: CAPTOR Study Manager; Phone Number: 09131 9278638; Email: captor@ifg-erlangen.de

Study Locations

• Germany
  • Amberg, Germany, 92224
    • Recruiting
    • Klinikum St Marien Amberg
    • Contact: Tanja H Haunzenberger, MD; Phone Number: +499621381381; Email: haunzenberger.tanja@klinikum-amberg.de
  • Aschaffenburg, Germany, 63739
    • Recruiting
    • Onkologie Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
    • Contact: Manfred Welslau, MD; Email: manfred.welslau@klinikum-ab-alz.de
  • Augsburg, Germany, 86156
    • Recruiting
    • University Hospital Augsburg
    • Contact: Nina Ditsch, MD, Prof.; Phone Number: +498214002208; Email: nina.ditsch@uk-augsburg.de
  • Augsburg, Germany, 86156
    • Not yet recruiting
    • Klinik für Hämatologie und Onkologie, Uniklinik Augsburg
    • Contact: Frank Jordan, MD; Email: Frank.Jordan@uk-augsburg.de
  • Bamberg, Germany, 96049
    • Not yet recruiting
    • Frauenklinik des Klinikums Bamberg
    • Contact: Denise Wrobel, MD; Email: studienzentrale@sozialstiftung-bamberg.de
  • Berlin, Germany, 13125
    • Not yet recruiting
    • Helios Klinikum Berlin-Buch
    • Contact: Michael Untch, MD; Email: michael.untch@helios-gesundheit.de
  • Berlin, Germany, 10367
    • Not yet recruiting
    • MediOnko GbR
    • Contact: Gülten Oskay-Özcelik, MD; Email: studienoskay@medionko.de
  • Bonn, Germany, 53129
    • Not yet recruiting
    • Zentrum für ambulante Hämatologie und Onkologie (ZAHO) an der Robert-Janker-Klinik
    • Contact: Martin Esser, MD; Email: messer@zaho-rheinland.de
  • Bremen, Germany, 28205
    • Not yet recruiting
    • Klinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte
    • Contact: Mustafa Aydogdu, MD; Email: studien_kbm_gyn@gesundheitnord.de
  • Chemnitz, Germany, 09116
    • Not yet recruiting
    • Klinikum Chemnitz gGmbH, Klinik für Frauenheilkunde und Geburtshilfe
    • Contact: Petra Krabisch, MD; Email: p.krabisch@skc.de
  • Cologne, Germany, 51067
    • Recruiting
    • Kliniken der Stadt Koln gGmbH
    • Contact: Myriam EM Vincent; Phone Number: +4922189076700; Email: vincentm@kliniken-koeln.de
  • Cottbus, Germany, 03048
    • Recruiting
    • Carl-Thiem-Klinikum Cottbus
    • Contact: Nikola Bangemann, MD; Email: N.Bangemann@ctk.de
  • Dessau, Germany, 06847
    • Recruiting
    • Staedtisches Klinikum Dessau, Gynecology and Obstetrics
    • Contact: Hermann Voß, MD; Phone Number: +493405014310; Email: hermann.voss@klinikum-dessau.de
  • Dresden, Germany, 01307
    • Not yet recruiting
    • Universitäts-Frauenklinik Carl Gustav Carus Universität Dresden
    • Contact: Pauline Wimberger, MD; Email: pauline.wimberger@uniklinikum-dresden.de
  • Duesseldorf, Germany, 40225
    • Recruiting
    • Universitaetsklinikum Duesseldorf AöR
    • Contact: Tanja Fehm, MD, Prof.; Phone Number: +492118117501; Email: direktion.frauenklinik@med.uni-duesseldorf.de
  • Essen, Germany, 45147
    • Not yet recruiting
    • Universitaetsklinikum Essen AöR, Gynecology and Obstetrics
    • Contact: Oliver Hoffmann, MD; Phone Number: +492017232575; Email: oliver.hoffmann@uk-essen.de
  • Esslingen, Germany, 73730
    • Not yet recruiting
    • Klinikum Esslingen GmbH
    • Contact: Alexander Hein, MD; Email: a.hein.cto@klinikum-esslingen.de
  • Frankfurt Am Main, Germany, 60431
    • Not yet recruiting
    • Agaplesion Frankfurter Diakonie Kliniken gGmbH, Gynecology and Obstetrics
    • Contact: Marc AM Thill, MD, Prof.; Phone Number: +496995332228; Email: marc.thill@agaplesion.de
  • Frankfurt am Main, Germany, 60596
    • Not yet recruiting
    • Universitäts-Frauenklinik Frankfurt
    • Contact: Christine Solbach, MD; Email: Christine.Solbach@kgu.de
  • Freiburg, Germany, 79106
    • Not yet recruiting
    • Universitäts-Frauenklinik Freiburg
    • Contact: Ingolf Juhasz-Böss, MD; Email: ingolf.juhasz-boess@uniklinik-freiburg.de
  • Georgsmarienhütte, Germany, 49124
    • Recruiting
    • Medizinisches Versorgungszentrum Onkologie Georgsmarienhütte und Bramsche
    • Contact: Kerstin Lüdtke-Heckenkamp, MD; Email: kerstin.luedtke-heckenkamp@niels-stensen-kliniken.de
  • Hamburg, Germany, 20246
    • Not yet recruiting
    • Universitäts-Frauenklinik Hamburg-Eppendorf
    • Contact: Volkmar Müller, MD; Email: v.mueller@uke.de
  • Hamburg, Germany, 20357
    • Not yet recruiting
    • Mammazentrum Hamburg am Krankenhaus Jerusalem
    • Contact: Christian Schem, MD; Email: schem@mammazentrum-hamburg.de
  • Heidelberg, Germany, 69120
    • Recruiting
    • Nationales Centrum für Tumorerkrankungen, Universitätsklinikum Heidelberg Abteilung für Gynäkologie und Geburtshilfe
    • Contact: Andreas Schneeweiss, MD; Email: Andreas.Schneeweiss@med.uni-heidelberg.de
  • Heilbronn, Germany, 74078
    • Recruiting
    • Frauenklinik, SLK-Kliniken Heilbronn GmbH
    • Contact: Nikolaus De Gregorio, MD; Email: nikolaus.degregorio@slk-kliniken.de
  • Karlsruhe, Germany, 76133
    • Recruiting
    • Staedtisches Klinikum Karlsruhe gGmbH, Gynecology and Obstetrics
    • Contact: Gariele Kaltenecker, MD; Phone Number: +4972197462406; Email: gabriele.kaltenecker@klinikum-karlsruhe.de
  • Kiel, Germany, 24105
    • Recruiting
    • University Medical Centre Schleswig-Holstein, Gynecology and Obstetrics
    • Contact: Marion van Mackelenbergh, MD; Phone Number: +4943150021410; Email: marion.vanmackelenbergh@uksh.de
  • Krefeld, Germany, 47805
    • Recruiting
    • ZAGO-Zentrum für ambulante gynäkologische Onkologie
    • Contact: Gunther M Rogmans, MD; Phone Number: +492151322969; Email: rogmans.gunther@gmail.com
  • Kulmbach, Germany, 95326
    • Recruiting
    • Klinikum Kulmbach
    • Contact: Benno Lex, MD; Phone Number: +499221981901; Email: benno.lex@klinikum-kulmbach.de
  • Landshut, Germany, 84036
    • Not yet recruiting
    • VK&K Studienzentrum Landshut am Lakumed Klinikum Landshut-Achdorf
    • Contact: Ursula Vehling-Kaiser, MD; Email: dr.vk@vehling-kaiser.de
  • Leer, Germany, 26789
    • Not yet recruiting
    • Praxis Dr. Müller MVM GmbH, Studienzentrum UnterEms
    • Contact: Lothar Müller, MD; Email: lothar.mueller@onkologie-ue.de
  • Leipzig, Germany, 04103
    • Not yet recruiting
    • Universitäts-Frauenklinik Leipzig
    • Contact: Bahriye Aktas, MD; Email: Bahriye.Aktas@medizin.uni-leipzig.de
  • Munich, Germany, 81241
    • Recruiting
    • Hämatologie Onkologie Gemeinschaftspraxis Pasing
    • Contact: Matthias Zingerle, MD; Email: zingerle@onkologie-pasing.de
  • Mönchengladbach, Germany, 41061
    • Not yet recruiting
    • Ev. Krankenhaus Bethesda Mönchengladbach
    • Contact: Iris Scheffen, MD; Email: iris.scheffen@wsg-online.com
  • Nordhausen, Germany, 99734
    • Recruiting
    • MVZ Nordhausen gGmbH
    • Contact: Andrea Grafe, MD; Email: andrea.grafe@shk-ndh.de
  • Nuremberg, Germany, 90419
    • Not yet recruiting
    • Klinikum Nürnberg
    • Contact: Christine Zeder-Göß, MD; Phone Number: +499113983843; Email: christine.zeder-goess@klinikum-nuernberg.de
  • Nürtingen, Germany, 72622
    • Recruiting
    • Frauenklinik, Medius Klinik Nürtingen
    • Contact: Elke Faust, MD; Email: e.faust@medius-kliniken.de
  • Ravensburg, Germany, 88212
    • Recruiting
    • Gemeinschaftspraxis für Hämatologie und Onkologie GbR
    • Contact: Thomas Decker, MD; Email: thomas.decker@onkonet.eu
  • Rotenburg, Germany, 27356
    • Recruiting
    • Frauenklinik, Diakoniekrankenhaus Rotenburg
    • Contact: Tobias Hesse, MD; Email: hesse@diako-online.de
  • Schweinfurt, Germany, 97422
    • Recruiting
    • Leopoldina Krankenhaus der Stadt Schweinfurt gGmbH
    • Contact: Michael Weigel, MD; Email: mweigel@leopoldina.de
  • Singen, Germany, 78224
    • Recruiting
    • Schwerpunktpraxis für Hämatologie, Onkologie und Magen-Darm Diagnostik
    • Contact: Thomas Fietz, MD; Email: studie@onkologie-bodensee.de
  • Speyer, Germany, 61346
    • Recruiting
    • Onkologische Schwerpunktpraxis Speyer
    • Contact: Gregor Bolz, MD; Email: g.bolz@onkologie-speyer.de
  • Stuttgart, Germany, 70174
    • Not yet recruiting
    • Klinikum Stuttgart
    • Contact: Ulrich Karck, MD; Email: u.karck@klinikum-stuttgart.de
  • Troisdorf, Germany, 53840
    • Not yet recruiting
    • Onkologie Rheinsieg, Praxisnetzwerk Hämatologie und internistische Onkologie
    • Contact: Ernst Rodermann, MD; Email: rodermann@onkologie-rheinsieg.de
  • Tuebingen, Germany, 72076
    • Recruiting
    • Universitaetsklinikum Tuebingen
    • Contact: Eva-Maria Grischke, MD, Prof.; Phone Number: +4970712982211; Email: eva-maria.grischke@med.uni-tuebingen.de
  • Ulm, Germany, 89075
    • Not yet recruiting
    • Universitäts-Frauenklinik Ulm
    • Contact: Brigitte Rack, MD; Email: Studienzentrale.UFK@uniklinik-ulm.de
  • Weiden, Germany, 92637
    • Not yet recruiting
    • MVZ Nordoberpfalz
    • Contact: Robert Funck, MD; Email: robert.funck@mvz-weiden.de
  • Westerstede, Germany, 26655
    • Recruiting
    • Medizinische Studiengesellschaft Nord-West GmbH
    • Contact: Jan Janssen, MD
  • Winnenden, Germany, 71364
    • Recruiting
    • Rems-Murr Kliniken Winnenden
    • Contact: Hans-Joachim Strittmatter, MD; Email: ans-joachim.strittmatter@rems-murr-kliniken.de
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Department of Gynecology and Obstetrics, Erlangen University Hospital
      • Contact: Peter A Fasching, MD, Prof.; Phone Number: +49 9131 8543470; Email: peter.fasching@uk-erlangen.de
  • Hesse
    • Mainz, Hesse, Germany, 55131
      • Recruiting
      • Department of Gynecology and Obstetrics, University Medicine Mainz
      • Contact: Marcus Schmidt, MD, Prof.; Phone Number: +49 6131 176884; Email: marcus.schmidt@unimedizin-mainz.de
  • North Rhine-Westphalia
    • Bottrop, North Rhine-Westphalia, Germany, 46236
      • Recruiting
      • Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH
      • Contact: Hans-Christian Kolberg, MD; Phone Number: +49 2041 1061601; Email: hans-christian.kolberg@mhb-bottrop.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ribociclib

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-month PFS rate	The rate for progression-free survival at month 24 will be calculated.	24 months
24-month OS rate	The rate for overall survival at month 24 will be calculated.	24 months
36-month PFS rate	The rate for progression-free survival at month 36 will be calculated.	36 months
36-month OS rate	The rate for overall survival at month 36 will be calculated.	36 months
Median progression-free survival	Median progression-free survival will be estimated if achieved at the end of study	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.
Median overall survival	Median overall survival will be estimated if achieved at the end of study	From date of enrollment until date of death from any cause or regular end of study (up to 24 months) whichever is first.
Health related quality of life (FACT-G)	Health related quality of life as assessed by FACT-G questionnaire (Functional Assessment of Cancer Therapy - General) Min 0, Max 108, The higher the score, the better the QoL.	Collected before start of trial treatment, at 3 months and every 6 months afterwards until end of study up to 24 months
Health related quality of life (FACT-B)	Health related quality of life as assessed by FACT-B questionnaire (Functional Assessment of Cancer Therapy - Breast Cancer) Min 0, Max 148, The higher the score, the better the QoL.	Collected before start of trial treatment, at 3 months and every 6 months afterwards until end of study up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	The safety endpoints for the study will include rate of adverse events (AE), serious adverse events (SAEs) and fatal SAEs, causality and outcome of AE/SAEs, rate of treatment discontinuations and reasons, Changes in vital signs, laboratory values etc. Grading of AE/SAEs will be based on NCI CTCAE v5.0.	All adverse events will be recorded from signing informed consent through 30 days following cessation of treatment or until the last study visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of genome wide genetic biomarkers with progression-free survival	Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.	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	Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.	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	Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.	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 ribociclib side effects	Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.	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 gene expression biomarkers with progression-free survival	Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.	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 gene expression biomarkers with overall survival	Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.	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 gene expression biomarkers with quality of life	Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.	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 gene expression biomarkers with ribociclib side effects	Genome wide genetic biomarkers will be assessed by whole genome sequencing and/ or panel sequencing from blood samples.	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 tumor mutational patterns assessed from formalin-fixed paraffin embedded tumor material with progression-free survival	Tumor DNA will be either isolated from FFPE tissue (primary tumor or metastasis) or from Plasma samples (STRECK cfDNA Tube). DNA will be analyzed by whole genome sequencing and/or panel sequencing.	Measured from biomaterial collected at baseline and at the time of tumor progression
Correlation of genome wide tumor mutational patterns assessed from formalin-fixed paraffin embedded tumor material with overall survival	Tumor DNA will be either isolated from FFPE tissue (primary tumor or metastasis) or from Plasma samples (STRECK cfDNA Tube). DNA will be analyzed by whole genome sequencing and/or panel sequencing.	Measured from biomaterial collected at baseline and at the time of tumor progression
Correlation of genome wide tumor mutational patterns assessed from formalin-fixed paraffin embedded tumor material with quality of life	Tumor DNA will be either isolated from FFPE tissue (primary tumor or metastasis) or from Plasma samples (STRECK cfDNA Tube). DNA will be analyzed by whole genome sequencing and/or panel sequencing.	Measured from biomaterial collected at baseline and at the time of tumor progression
Correlation of genome wide tumor mutational patterns assessed from formalin-fixed paraffin embedded tumor material with ribociclib side effects	Tumor DNA will be either isolated from FFPE tissue (primary tumor or metastasis) or from Plasma samples (STRECK cfDNA Tube). DNA will be analyzed by whole genome sequencing and/or panel sequencing.	Measured from biomaterial collected at baseline and at the time of tumor progression
Correlation of genome wide tumor mutational patterns assessed from ctDNA biomarkers with progression-free survival	Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.	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 tumor mutational patterns assessed from ctDNA biomarkers with overall survival	Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.	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 tumor mutational patterns assessed from ctDNA biomarkers with quality of life	Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.	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 tumor mutational patterns assessed from ctDNA biomarkers with ribociclib side effects	Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.	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 changes in the genome wide tumor mutational patterns assessed from ctDNA biomarkers with progression-free survival	Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.	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 changes in the genome wide tumor mutational patterns assessed from ctDNA biomarkers with overall survival	Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.	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 changes in the genome wide tumor mutational patterns assessed from ctDNA biomarkers with quality of life	Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.	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 changes in the genome wide tumor mutational patterns assessed from ctDNA biomarkers with ribociclib side effects	Germline DNA will be isolated from one EDTA blood samples obtained within the study. DNA will be analyzed by whole genome sequencing and/or panel sequencing.	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.

Collaborators and Investigators

• Sponsor: Institut fuer Frauengesundheit
• Collaborators: Novartis Pharmaceuticals; AGO Breast Study Group e.V.
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: IFG-01-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No