Breast CancerPhase 4CAPTOR-BCNCT05452213
Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
A Phase 4 study testing Ribociclib in people with Breast Cancer and Breast Neoplasms, run by Institut fuer Frauengesundheit at 52 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Neoplasm Female
- What is being tested?
- Ribociclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 52 sitesGermany
- Study dates
- 12 Oct 2022to Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
Germany52 sites, 52 recruiting
- Recruiting
Klinikum St Marien Amberg
Amberg, 92224
Tanja H Haunzenberger, MD, +499621381381, haunzenberger.tanja@klinikum-amberg.de
- Recruiting
Onkologie Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
Aschaffenburg, 63739
Manfred Welslau, MD, manfred.welslau@klinikum-ab-alz.de
- Not yet recruiting
Klinik für Hämatologie und Onkologie, Uniklinik Augsburg
Augsburg, 86156
Frank Jordan, MD, Frank.Jordan@uk-augsburg.de
- Recruiting
University Hospital Augsburg
Augsburg, 86156
Nina Ditsch, MD, Prof., +498214002208, nina.ditsch@uk-augsburg.de
- Not yet recruiting
Frauenklinik des Klinikums Bamberg
Bamberg, 96049
Denise Wrobel, MD, studienzentrale@sozialstiftung-bamberg.de
- Not yet recruiting
MediOnko GbR
Berlin, 10367
Gülten Oskay-Özcelik, MD, studienoskay@medionko.de
- Not yet recruiting
HELIOS Klinikum Berlin-Buch
Berlin, 13125
Michael Untch, MD, michael.untch@helios-gesundheit.de
- Not yet recruiting
Zentrum für ambulante Hämatologie und Onkologie (ZAHO) an der Robert-Janker-Klinik
Bonn, 53129
Martin Esser, MD, messer@zaho-rheinland.de
- Recruiting
Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH
Bottrop, North Rhine-Westphalia, 46236
Hans-Christian Kolberg, MD, +49 2041 1061601, hans-christian.kolberg@mhb-bottrop.de
- Not yet recruiting
Klinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte
Bremen, 28205
Mustafa Aydogdu, MD, studien_kbm_gyn@gesundheitnord.de
- Not yet recruiting
Klinikum Chemnitz gGmbH, Klinik für Frauenheilkunde und Geburtshilfe
Chemnitz, 09116
Petra Krabisch, MD, p.krabisch@skc.de
- Recruiting
Kliniken Der Stadt Köln gGmbH
Cologne, 51067
Myriam EM Vincent, +4922189076700, vincentm@kliniken-koeln.de
- Recruiting
Carl-Thiem-Klinikum Cottbus
Cottbus, 03048
Nikola Bangemann, MD, N.Bangemann@ctk.de
- Recruiting
Staedtisches Klinikum Dessau, Gynecology and Obstetrics
Dessau, 06847
Hermann Voß, MD, +493405014310, hermann.voss@klinikum-dessau.de
- Not yet recruiting
Universitäts-Frauenklinik Carl Gustav Carus Universität Dresden
Dresden, 01307
Pauline Wimberger, MD, pauline.wimberger@uniklinikum-dresden.de
- Recruiting
Universitaetsklinikum Duesseldorf AöR
Düsseldorf, 40225
Tanja Fehm, MD, Prof., +492118117501, direktion.frauenklinik@med.uni-duesseldorf.de
- Recruiting
Department of Gynecology and Obstetrics, Erlangen University Hospital
Erlangen, Bavaria, 91054
Peter A Fasching, MD, Prof., +49 9131 8543470, peter.fasching@uk-erlangen.de
- Not yet recruiting
Universitaetsklinikum Essen AöR, Gynecology and Obstetrics
Essen, 45147
Oliver Hoffmann, MD, +492017232575, oliver.hoffmann@uk-essen.de
- Not yet recruiting
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Alexander Hein, MD, a.hein.cto@klinikum-esslingen.de
- Not yet recruiting
Agaplesion Frankfurter Diakonie Kliniken gGmbH, Gynecology and Obstetrics
Frankfurt am Main, 60431
Marc AM Thill, MD, Prof., +496995332228, marc.thill@agaplesion.de
- Not yet recruiting
Universitäts-Frauenklinik Frankfurt
Frankfurt am Main, 60596
Christine Solbach, MD, Christine.Solbach@kgu.de
- Not yet recruiting
Universitäts-Frauenklinik Freiburg
Freiburg im Breisgau, 79106
Ingolf Juhasz-Böss, MD, ingolf.juhasz-boess@uniklinik-freiburg.de
- Recruiting
Medizinisches Versorgungszentrum Onkologie Georgsmarienhütte und Bramsche
Georgsmarienhütte, 49124
Kerstin Lüdtke-Heckenkamp, MD, kerstin.luedtke-heckenkamp@niels-stensen-kliniken.de
- Not yet recruiting
Universitäts-Frauenklinik Hamburg-Eppendorf
Hamburg, 20246
Volkmar Müller, MD, v.mueller@uke.de
- Not yet recruiting
Mammazentrum Hamburg am Krankenhaus Jerusalem
Hamburg, 20357
Christian Schem, MD, schem@mammazentrum-hamburg.de
- Recruiting
Nationales Centrum für Tumorerkrankungen, Universitätsklinikum Heidelberg Abteilung für Gynäkologie und Geburtshilfe
Heidelberg, 69120
Andreas Schneeweiss, MD, Andreas.Schneeweiss@med.uni-heidelberg.de
- Recruiting
Frauenklinik, SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078
Nikolaus De Gregorio, MD, nikolaus.degregorio@slk-kliniken.de
- Recruiting
Staedtisches Klinikum Karlsruhe gGmbH, Gynecology and Obstetrics
Karlsruhe, 76133
Gariele Kaltenecker, MD, +4972197462406, gabriele.kaltenecker@klinikum-karlsruhe.de
- Recruiting
University Medical Centre Schleswig-Holstein, Gynecology and Obstetrics
Kiel, 24105
Marion van Mackelenbergh, MD, +4943150021410, marion.vanmackelenbergh@uksh.de
- Recruiting
ZAGO-Zentrum für ambulante gynäkologische Onkologie
Krefeld, 47805
Gunther M Rogmans, MD, +492151322969, rogmans.gunther@gmail.com
- Recruiting
Klinikum Kulmbach
Kulmbach, 95326
Benno Lex, MD, +499221981901, benno.lex@klinikum-kulmbach.de
- Not yet recruiting
VK&K Studienzentrum Landshut am Lakumed Klinikum Landshut-Achdorf
Landshut, 84036
Ursula Vehling-Kaiser, MD, dr.vk@vehling-kaiser.de
- Not yet recruiting
Praxis Dr. Müller MVM GmbH, Studienzentrum UnterEms
Leer, 26789
Lothar Müller, MD, lothar.mueller@onkologie-ue.de
- Not yet recruiting
Universitäts-Frauenklinik Leipzig
Leipzig, 04103
Bahriye Aktas, MD, Bahriye.Aktas@medizin.uni-leipzig.de
- Recruiting
Department of Gynecology and Obstetrics, University Medicine Mainz
Mainz, Hesse, 55131
Marcus Schmidt, MD, Prof., +49 6131 176884, marcus.schmidt@unimedizin-mainz.de
- Not yet recruiting
Ev. Krankenhaus Bethesda Mönchengladbach
Mönchengladbach, 41061
Iris Scheffen, MD, iris.scheffen@wsg-online.com
- Recruiting
Hämatologie Onkologie Gemeinschaftspraxis Pasing
Munich, 81241
Matthias Zingerle, MD, zingerle@onkologie-pasing.de
- Recruiting
MVZ Nordhausen gGmbH
Nordhausen, 99734
Andrea Grafe, MD, andrea.grafe@shk-ndh.de
- Not yet recruiting
Klinikum Nürnberg
Nuremberg, 90419
Christine Zeder-Göß, MD, +499113983843, christine.zeder-goess@klinikum-nuernberg.de
- Recruiting
Frauenklinik, Medius Klinik Nürtingen
Nürtingen, 72622
Elke Faust, MD, e.faust@medius-kliniken.de
- Recruiting
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
Ravensburg, 88212
Thomas Decker, MD, thomas.decker@onkonet.eu
- Recruiting
Frauenklinik, Diakoniekrankenhaus Rotenburg
Rotenburg (Wümme), 27356
Tobias Hesse, MD, hesse@diako-online.de
- Recruiting
Leopoldina Krankenhaus der Stadt Schweinfurt gGmbH
Schweinfurt, 97422
Michael Weigel, MD, mweigel@leopoldina.de
- Recruiting
Schwerpunktpraxis für Hämatologie, Onkologie und Magen-Darm Diagnostik
Singen, 78224
Thomas Fietz, MD, studie@onkologie-bodensee.de
- Recruiting
Onkologische Schwerpunktpraxis Speyer
Speyer, 61346
Gregor Bolz, MD, g.bolz@onkologie-speyer.de
- Not yet recruiting
Klinikum Stuttgart
Stuttgart, 70174
Ulrich Karck, MD, u.karck@klinikum-stuttgart.de
- Not yet recruiting
Onkologie Rheinsieg, Praxisnetzwerk Hämatologie und internistische Onkologie
Troisdorf, 53840
Ernst Rodermann, MD, rodermann@onkologie-rheinsieg.de
- Recruiting
Universitaetsklinikum Tuebingen
Tübingen, 72076
Eva-Maria Grischke, MD, Prof., +4970712982211, eva-maria.grischke@med.uni-tuebingen.de
- Not yet recruiting
Universitäts-Frauenklinik Ulm
Ulm, 89075
Brigitte Rack, MD, Studienzentrale.UFK@uniklinik-ulm.de
- Not yet recruiting
MVZ Nordoberpfalz
Weiden, 92637
Robert Funck, MD, robert.funck@mvz-weiden.de
- Recruiting
Medizinische Studiengesellschaft Nord-West GmbH
Westerstede, 26655
Jan Janssen, MD
- Recruiting
Rems-Murr Kliniken Winnenden
Winnenden, 71364
Hans-Joachim Strittmatter, MD, ans-joachim.strittmatter@rems-murr-kliniken.de
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Neoplasm Female, Breast Cancer Female, HER2-negative Breast Cancer, Hormone Receptor-positive Breast Cancer
- Being tested
- Ribociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibociclibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib | Experimental | Not described Receives: Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month PFS rate
The rate for progression-free survival at month 12 will be calculated.
Measured: 12 months
12-month OS rate
The rate for overall survival at month 12 will be calculated.
Measured: 12 months
Secondary outcomes (9)
24-month PFS rate
The rate for progression-free survival at month 24 will be calculated.
Measured: 24 months
24-month OS rate
The rate for overall survival at month 24 will be calculated.
Measured: 24 months
36-month PFS rate
The rate for progression-free survival at month 36 will be calculated.
Measured: 36 months
36-month OS rate
The rate for overall survival at month 36 will be calculated.
Measured: 36 months
Median progression-free survival
Median progression-free survival will be estimated if achieved at the end of study
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: All adverse events will be recorded from signing informed consent through 30 days following cessation of treatment or until the last study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start12 Oct 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One-arm, open-label
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut fuer Frauengesundheit
- Sponsor type
- University, hospital or other
- Collaborators
- AGO Breast Study Group e.V., Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Peter A. Fasching, MD, Prof., Study chair, Department of Gynecology and Obstetrics, Erlangen University HospitalTanja Fehm, MD, Prof., Study chair, Department of Gynecology/Obstetrics |University Hospital Düsseldorf, GermanyAndreas Schneeweiss, MD, Prof., Study chair, National Center for Tumor Diseases (NCT) | Heidelberg University Hospital and German Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452213
- Sponsor's protocol ID
- IFG-01-2022
- Acronym
- CAPTOR-BC
- Status last verified
- Apr 2023
- First submitted
- 28 Jun 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPTOR-BC: Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05452213
- Acronym / sponsor ID
- CAPTOR-BC / IFG-01-2022
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Neoplasm Female, Breast Cancer Female, HER2-negative Breast Cancer, Hormone Receptor-positive Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institut fuer FrauengesundheitUniversity, hospital or other
- Collaborators
- AGO Breast Study Group e.V., Novartis Pharmaceuticals
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One-arm, open-label
| Arm | Type | Receives |
|---|---|---|
| Ribociclib | Experimental | Drug: Ribociclib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibociclibAll 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. | Drug | Ribociclib |
Primary outcome
12-month PFS rate
Time frame: 12 months
The rate for progression-free survival at month 12 will be calculated.
12-month OS rate
Time frame: 12 months
The rate for overall survival at month 12 will be calculated.
9 secondary outcomes
24-month PFS rate
Time frame: 24 months
24-month OS rate
Time frame: 24 months
36-month PFS rate
Time frame: 36 months
36-month OS rate
Time frame: 36 months
Median progression-free survival
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: All adverse events will be recorded from signing informed consent through 30 days following cessation of treatment or until the last study visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A. Fasching, MD, Prof. study chair
Department of Gynecology and Obstetrics, Erlangen University Hospital
Tanja Fehm, MD, Prof. study chair
Department of Gynecology/Obstetrics |University Hospital Düsseldorf, Germany
Andreas Schneeweiss, MD, Prof. study chair
National Center for Tumor Diseases (NCT) | Heidelberg University Hospital and German Cancer Research Center
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ribociclib in people with Breast Cancer and Breast Neoplasms, run by Institut fuer Frauengesundheit at 52 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CAPTOR Study Manager (09131 9278638, captor@ifg-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month PFS rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.