Actively Recruiting
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
207 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
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
Official 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...
- Female patients aged 18 years or older
- Indicated for ribociclib combined with endocrine therapy for locally advanced or first-line metastatic breast cancer according to current product guidelines
- Locally advanced or metastatic breast cancer not treatable with curative intent
- HER2-negative breast cancer confirmed by local lab tests
- Estrogen receptor positive and/or progesterone receptor positive breast cancer confirmed by biopsy
- Corrected QT interval (QTcF) less than 450 ms
- Adequate organ function for ribociclib treatment
- Negative pregnancy test within 72 hours before study start for women of childbearing potential
- Willingness to use effective contraception during the study and for 21 days after last dose
- Ability and willingness to comply with study visits, treatments, and tests
You will not qualify if you...
- Participation in another clinical study with investigational agents/devices within 14 days or 5 half-lives prior to study entry
- Not receiving ribociclib as first-line therapy for advanced HR+/HER2- breast cancer
- Not eligible for ribociclib treatment per product guidelines or investigator decision
- Pregnant or breastfeeding women
- Significant risk or history of QT interval prolongation, including long QT syndrome or serious cardiac disease
- Known hypersensitivity to ribociclib or its excipients such as soya or peanut
- Active systemic infections requiring systemic therapy or detectable viral infections such as HIV or hepatitis B/C
- Serious preexisting medical conditions that may interfere with study participation, including severe renal impairment, lung disease, major gastrointestinal surgery, or chronic inflammatory bowel disease
- Refusal to provide biospecimen samples such as blood, stool, or tissue
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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