Actively Recruiting
Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management
Led by Prof. Wolfgang Janni · Updated on 2025-05-16
300
Participants Needed
54
Research Sites
361 weeks
Total Duration
On this page
Sponsors
P
Prof. Wolfgang Janni
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
The MINERVA Trial aims to evaluate safety, efficacy and quality of life (QoL) for the combination of Abemaciclib with an Aromatase Inhibitor or Fulvestrant in pre- and postmenopausal patients with metastatic hormone receptor positive HER2 negative breast cancer in the first line setting. Side effect monitoring and patient reported outcomes will be captured using the web- and app-based CANKADO digital health application. Via this user-friendly tool the patients can document their therapy side effects (e.g. diarrhea) and outcomes on a day-to-day basis. The capturing of side effects using the digital health application will be done additionally to the regular AE documentation. Furthermore, translational research objectives of this trial include the investigation of biomarkers (ct-DNA, germline DNA) to evaluate whether they can give insights into the reasons for response, intrinsic or acquired resistance to the combined endocrine
CONDITIONS
Official Title
Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any trial procedures
- Female aged 18 years or older
- Diagnosed with hormone receptor positive, HER2 negative breast cancer
- Have locally advanced recurrent or metastatic disease not suitable for surgery or radiation
- Eligible for endocrine therapy in metastatic setting
- ECOG performance status of 0 to 2
- Stable central nervous system metastases if present
- Pre- or postmenopausal status; women of childbearing potential must use highly effective contraception
- No prior therapy for metastatic disease except up to 3 months of first-line endocrine therapy without progression
- Prior adjuvant endocrine therapy or chemotherapy allowed if recovered from side effects
- Completed radiotherapy with recovery from effects
- Measurable disease or evaluable bone-only disease per RECIST v1.1 criteria
- Adequate bone marrow and organ function based on specific laboratory tests
- Able to swallow oral medications
- Willing to use the CANKADO digital health app for side effect reporting (recommended but not mandatory)
- Negative pregnancy test before trial start for women of childbearing potential
You will not qualify if you...
- Visceral crisis or life expectancy less than 6 months
- Hypersensitivity to Abemaciclib or drug components
- Prior chemotherapy or endocrine therapy for metastatic disease beyond allowed exceptions
- Not eligible for endocrine therapy
- Severe uncontrolled diseases or psychiatric conditions affecting treatment adherence
- Serious uncontrolled preexisting medical conditions such as interstitial lung disease or severe diarrhea
- Prior treatment with CDK4/6 inhibitors for metastatic disease except limited cases
- Treatment with other investigational agents within 4 weeks or 5 half-lives before trial
- History of serious cardiac conditions like ventricular arrhythmia or sudden cardiac arrest
- Pregnant or breastfeeding females
- Legal incapacity or limited legal capacity
- History of other cancers unless in remission without therapy for at least 3 years
- Active systemic infections requiring IV antibiotics or known active viral infections
- Recent systemic anti-cancer therapy or radiotherapy within specified washout periods
- Major surgery within 14 days before trial registration
AI-Screening
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Trial Site Locations
Total: 54 locations
1
Kliniken Ostalb gkAöR
Aalen, Germany
Actively Recruiting
2
Klinikum St. Marien Kommunalunternehmen - AöR Der Stadt Amberg
Amberg, Germany
Actively Recruiting
3
Klinikum Aschaffenburg-Alzenau gGmbH
Aschaffenburg, Germany
Actively Recruiting
4
Gemeinschaftspraxis Dr. Heinrich / Dr. Bangerter
Augsburg, Germany
Actively Recruiting
5
Universitätsklinikum Augsburg A.d.ö.R
Augsburg, Germany
Actively Recruiting
6
MediOnko-Institut GbR
Berlin, Germany
Actively Recruiting
7
Hämatologikum Biberach
Biberach, Germany
Actively Recruiting
8
Gynäkologisches Zentrum Bonn - Friedensplatz
Bonn, Germany
Actively Recruiting
9
Studien GbR Braunschweig
Braunschweig, Germany
Actively Recruiting
10
Hämato-Onkologische Praxis im Medicum
Bremen, Germany
Actively Recruiting
11
St. Elisabeth-Krankenhaus GmbH
Cologne, Germany
Actively Recruiting
12
Onkologisches Zentrum Donauwörth
Donauwörth, Germany
Actively Recruiting
13
Gemeinschaftspraxis
Dresden, Germany
Actively Recruiting
14
Onkozentrum Dresden
Dresden, Germany
Actively Recruiting
15
MVZ Medical Center Düsseldorf GmbH
Düsseldorf, Germany
Actively Recruiting
16
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Actively Recruiting
17
Internistische Praxis Ehingen
Ehingen, Germany
Actively Recruiting
18
Universitätsklinikum Erlangen
Erlangen, Germany
Actively Recruiting
19
St. Antonius-Hospital
Eschweiler, Germany
Actively Recruiting
20
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt, Germany
Actively Recruiting
21
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Actively Recruiting
22
Krankenhäuser Landkreis Freudenstadt gGmbH
Freudenstadt, Germany
Actively Recruiting
23
Internistische Gemeinschaftspraxis
Friedrichshafen, Germany
Actively Recruiting
24
Klinikum Garmisch-Partenkirchen GmbH
Garmisch-Partenkirchen, Germany
Actively Recruiting
25
Main-Kinzig-Kliniken gGmbH Gelnhausen
Gelnhausen, Germany
Actively Recruiting
26
Gemeinschaftspraxis und Tagesklinik Halle
Halle, Germany
Actively Recruiting
27
Albertinen-Krankenhaus
Hamburg, Germany
Actively Recruiting
28
Sana Klinikum Hameln-Pyrmont
Hamelin, Germany
Actively Recruiting
29
Frauenärzte am Bahnhofsplatz
Hildesheim, Germany
Actively Recruiting
30
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, Germany
Actively Recruiting
31
Klinikum Kassel GmbH
Kassel, Germany
Actively Recruiting
32
Klinikverbund Kempten-Oberallgäu gGmbH
Kempten, Germany
Actively Recruiting
33
Klinikum Konstanz
Konstanz, Germany
Actively Recruiting
34
ZAGO- Zentrum für ambulante gynäkologische Onkologie
Krefeld, Germany
Actively Recruiting
35
Krankenhausgesellschaft St. Vincenz mbH
Limburg, Germany
Actively Recruiting
36
Praxis für gynäkologische Onkologie / Prof. Dr. med. Ulrike Nitz / Raquel von Schumann
Mönchengladbach, Germany
Actively Recruiting
37
Kliniken Ostalb gkAöR, Stauferklinikum Schwäbisch Gmünd
Mutlangen, Germany
Actively Recruiting
38
LMU - Klinikum der Universität München
München, Germany
Actively Recruiting
39
München Klinik gGmbH Harlaching
München, Germany
Actively Recruiting
40
TZN-Tumorzentrum Niederrhein GmbH
Neuss, Germany
Actively Recruiting
41
Klinikum Nürnberg Nord
Nuremberg, Germany
Actively Recruiting
42
medius KLINIK NÜRTINGEN
Nürtingen, Germany
Actively Recruiting
43
Praxis Dr. Guth
Plauen, Germany
Actively Recruiting
44
Klinikum Ernst von Bergmann gGmbH
Potsdam, Germany
Actively Recruiting
45
Klinikum Rheine
Rheine, Germany
Actively Recruiting
46
GPR Gesundheits- und Pflegezentrum Rüsselsheim gGmbH
Rüsselsheim am Main, Germany
Actively Recruiting
47
Diakoneo Diak-Klinikum Schwäbisch Hall gGmbH
Schwäbisch Hall, Germany
Actively Recruiting
48
Clinical Research Stolberg GmbH
Stolberg, Germany
Actively Recruiting
49
Gynäkologie Kompetenzzentrum Stralsund
Stralsund, Germany
Actively Recruiting
50
Universitätsfrauenklinik Tübingen
Tübingen, Germany
Actively Recruiting
51
University Hospital Ulm Gynecology/Obstetrics
Ulm, Germany
Actively Recruiting
52
St. Josefs-Hospital
Wiesbaden, Germany
Actively Recruiting
53
Spital Wallis
Brig, Switzerland
Actively Recruiting
54
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
Research Team
N
Natalie Uhl
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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