Actively Recruiting
CAPTOR-BC: Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Led by Institut fuer Frauengesundheit · Updated on 2023-04-18
1000
Participants Needed
52
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
Institut fuer Frauengesundheit
Lead Sponsor
A
AGO Breast Study Group e.V.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating ribociclib combined with standard endocrine therapy for women with advanced hormone receptor-positive (HR+) and HER2-negative breast cancer receiving first-line treatment. This phase IV, open-label study aims to understand how ribociclib works over time and identify patterns of resistance. The study also focuses on survival rates at 12 months and includes a comprehensive program to discover and validate biomarkers related to treatment outcomes. Participants will receive ribociclib once daily for 21 days followed by 7 days off, in 28-day cycles, alongside standard endocrine therapy prescribed by their doctors. The treatment follows the approved guidelines (Summary of Product Characteristics) for ribociclib. This trial plans to enroll 1000 female patients across 75 sites in Germany and involves extensive biomarker sampling from blood, tissue, and immune cells before, during, and after treatment or disease progression. During the study, participants will have regular assessments including survival monitoring at various time points up to 36 months, quality of life evaluations, and safety checks for treatment-related side effects. Samples for biomarker research will be collected to help understand treatment response. Follow-up includes collecting data on progression-free and overall survival, quality of life, and adverse events, with total study involvement lasting up to 36 months.
CONDITIONS
Brief Title
Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for treatment with ribociclib combined with endocrine therapy for locally advanced or first-line metastatic breast cancer according to SmPC
- Signed informed consent before any trial-specific procedures
- Female aged 18 years or older at consent
- Locally advanced or metastatic breast cancer not suitable for curative treatment
- HER2-negative breast cancer confirmed by local lab tests including immunohistochemistry and in situ hybridization as needed
- Histologically confirmed estrogen receptor (ER) positive and/or progesterone receptor (PgR) positive breast cancer by core biopsy
- Corrected QT interval (QTcF) less than 450 ms
- Adequate organ function for ribociclib treatment as per local labs
- For women of childbearing potential, negative pregnancy test within 72 hours before study entry and agreement to use effective contraception during and 21 days after treatment
- Willingness and ability to comply with study visits, treatments, lab tests, and procedures
You will not qualify if you...
- Participation in another trial with an investigational drug or device within 14 days or 5 half-lives before study entry
- Not treated for advanced HR+, HER2- breast cancer as first-line therapy
- Ineligibility for ribociclib treatment as per SmPC or investigator decision
- Pregnancy or lactation
- Existing or high risk of corrected QT interval prolongation, including long QT syndrome, serious cardiac disease, or electrolyte imbalances
- Known allergy to ribociclib, soya, peanut, or its excipients
- Active systemic infections requiring systemic treatment or known active viral infections like HIV or hepatitis B/C
- Serious medical conditions that could interfere with study participation, such as severe renal impairment, lung disease, oxygen-dependent breathing difficulties, prior major stomach or bowel surgery, inflammatory bowel diseases, or chronic diarrhea
- Refusal to provide biospecimens such as blood, stool, or tissue samples
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants receive ribociclib daily for 21 days followed by 7 days off in 28-day cycles, combined with standard endocrine therapy according to the current treatment guidelines.
Visits scheduled according to treatment cycles and monitoring requirements
Duration - Up to 24 months after treatment initiation
Participants are monitored for progression-free survival, overall survival, quality of life, and adverse events up to 24 months after starting treatment.
Visits at 3 months and every 6 months thereafter until end of study
Trial Site Locations
Total: 52 locations
1
Department of Gynecology and Obstetrics, Erlangen University Hospital
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
2
Department of Gynecology and Obstetrics, University Medicine Mainz
Mainz, Hesse, Germany, 55131
Actively Recruiting
3
Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH
Bottrop, North Rhine-Westphalia, Germany, 46236
Actively Recruiting
4
Klinikum St Marien Amberg
Amberg, Germany, 92224
Actively Recruiting
5
Onkologie Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
Aschaffenburg, Germany, 63739
Actively Recruiting
6
Klinik für Hämatologie und Onkologie, Uniklinik Augsburg
Augsburg, Germany, 86156
Not Yet Recruiting
7
University Hospital Augsburg
Augsburg, Germany, 86156
Actively Recruiting
8
Frauenklinik des Klinikums Bamberg
Bamberg, Germany, 96049
Not Yet Recruiting
9
MediOnko GbR
Berlin, Germany, 10367
Not Yet Recruiting
10
HELIOS Klinikum Berlin-Buch
Berlin, Germany, 13125
Not Yet Recruiting
11
Zentrum für ambulante Hämatologie und Onkologie (ZAHO) an der Robert-Janker-Klinik
Bonn, Germany, 53129
Not Yet Recruiting
12
Klinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte
Bremen, Germany, 28205
Not Yet Recruiting
13
Klinikum Chemnitz gGmbH, Klinik für Frauenheilkunde und Geburtshilfe
Chemnitz, Germany, 09116
Not Yet Recruiting
14
Kliniken Der Stadt Köln gGmbH
Cologne, Germany, 51067
Actively Recruiting
15
Carl-Thiem-Klinikum Cottbus
Cottbus, Germany, 03048
Actively Recruiting
16
Staedtisches Klinikum Dessau, Gynecology and Obstetrics
Dessau, Germany, 06847
Actively Recruiting
17
Universitäts-Frauenklinik Carl Gustav Carus Universität Dresden
Dresden, Germany, 01307
Not Yet Recruiting
18
Universitaetsklinikum Duesseldorf AöR
Düsseldorf, Germany, 40225
Actively Recruiting
19
Universitaetsklinikum Essen AöR, Gynecology and Obstetrics
Essen, Germany, 45147
Not Yet Recruiting
20
Klinikum Esslingen GmbH
Esslingen am Neckar, Germany, 73730
Not Yet Recruiting
21
Agaplesion Frankfurter Diakonie Kliniken gGmbH, Gynecology and Obstetrics
Frankfurt am Main, Germany, 60431
Not Yet Recruiting
22
Universitäts-Frauenklinik Frankfurt
Frankfurt am Main, Germany, 60596
Not Yet Recruiting
23
Universitäts-Frauenklinik Freiburg
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
24
Medizinisches Versorgungszentrum Onkologie Georgsmarienhütte und Bramsche
Georgsmarienhütte, Germany, 49124
Actively Recruiting
25
Universitäts-Frauenklinik Hamburg-Eppendorf
Hamburg, Germany, 20246
Not Yet Recruiting
26
Mammazentrum Hamburg am Krankenhaus Jerusalem
Hamburg, Germany, 20357
Not Yet Recruiting
27
Nationales Centrum für Tumorerkrankungen, Universitätsklinikum Heidelberg Abteilung für Gynäkologie und Geburtshilfe
Heidelberg, Germany, 69120
Actively Recruiting
28
Frauenklinik, SLK-Kliniken Heilbronn GmbH
Heilbronn, Germany, 74078
Actively Recruiting
29
Staedtisches Klinikum Karlsruhe gGmbH, Gynecology and Obstetrics
Karlsruhe, Germany, 76133
Actively Recruiting
30
University Medical Centre Schleswig-Holstein, Gynecology and Obstetrics
Kiel, Germany, 24105
Actively Recruiting
31
ZAGO-Zentrum für ambulante gynäkologische Onkologie
Krefeld, Germany, 47805
Actively Recruiting
32
Klinikum Kulmbach
Kulmbach, Germany, 95326
Actively Recruiting
33
VK&K Studienzentrum Landshut am Lakumed Klinikum Landshut-Achdorf
Landshut, Germany, 84036
Not Yet Recruiting
34
Praxis Dr. Müller MVM GmbH, Studienzentrum UnterEms
Leer, Germany, 26789
Not Yet Recruiting
35
Universitäts-Frauenklinik Leipzig
Leipzig, Germany, 04103
Not Yet Recruiting
36
Ev. Krankenhaus Bethesda Mönchengladbach
Mönchengladbach, Germany, 41061
Not Yet Recruiting
37
Hämatologie Onkologie Gemeinschaftspraxis Pasing
Munich, Germany, 81241
Actively Recruiting
38
MVZ Nordhausen gGmbH
Nordhausen, Germany, 99734
Actively Recruiting
39
Klinikum Nürnberg
Nuremberg, Germany, 90419
Not Yet Recruiting
40
Frauenklinik, Medius Klinik Nürtingen
Nürtingen, Germany, 72622
Actively Recruiting
41
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
Ravensburg, Germany, 88212
Actively Recruiting
42
Frauenklinik, Diakoniekrankenhaus Rotenburg
Rotenburg (Wümme), Germany, 27356
Actively Recruiting
43
Leopoldina Krankenhaus der Stadt Schweinfurt gGmbH
Schweinfurt, Germany, 97422
Actively Recruiting
44
Schwerpunktpraxis für Hämatologie, Onkologie und Magen-Darm Diagnostik
Singen, Germany, 78224
Actively Recruiting
45
Onkologische Schwerpunktpraxis Speyer
Speyer, Germany, 61346
Actively Recruiting
46
Klinikum Stuttgart
Stuttgart, Germany, 70174
Not Yet Recruiting
47
Onkologie Rheinsieg, Praxisnetzwerk Hämatologie und internistische Onkologie
Troisdorf, Germany, 53840
Not Yet Recruiting
48
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
49
Universitäts-Frauenklinik Ulm
Ulm, Germany, 89075
Not Yet Recruiting
50
MVZ Nordoberpfalz
Weiden, Germany, 92637
Not Yet Recruiting
51
Medizinische Studiengesellschaft Nord-West GmbH
Westerstede, Germany, 26655
Actively Recruiting
52
Rems-Murr Kliniken Winnenden
Winnenden, Germany, 71364
Actively Recruiting
Research Team
C
CAPTOR Study Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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