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
NCT ID: NCT05362760
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2022-04-27
2029-04-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Abemaciclib + Aromatase-Inhibitor
The patients will receive Abemaciclib in combination with an Aromatase-Inhibitor (either Anastrozole, Letrozole or exemestane)
Abemaciclib + Aromatase Inhibitor
Abemaciclib 150 mg orally every 12 hours plus Aromatase Inhibitor ( Anastrozole 1 mg, Letrozole 2.5 mg or exemestane 25 mg orally every 24 hours on Days 1 to 28 of a 28-day cycle)
Abemaciclib + Fulvestrant
The patients will receive Abemaciclib in combination Fulvestrant
Abemaciclib + Fulvestrant
Abemaciclib 150 mg orally every 12 hours plus Fulvestrant (500 mg intramuscularly on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on Day 1 of a 28-day cycle)
Interventions
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Abemaciclib + Aromatase Inhibitor
Abemaciclib 150 mg orally every 12 hours plus Aromatase Inhibitor ( Anastrozole 1 mg, Letrozole 2.5 mg or exemestane 25 mg orally every 24 hours on Days 1 to 28 of a 28-day cycle)
Abemaciclib + Fulvestrant
Abemaciclib 150 mg orally every 12 hours plus Fulvestrant (500 mg intramuscularly on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on Day 1 of a 28-day cycle)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Have given written informed consent prior to any trial-specific procedures
2. Are reliable, willing to be available for the duration of the trial and are willing to follow trial procedures
3. Are female and aged ≥ 18 years
4. Diagnosis of hormone receptor positive (HR+), HER2- breast cancer. Although not required as a protocol procedure, metastatic disease should be considered for biopsy whenever possible to reassess HR and HER2 status if clinically indicated.
5. To fulfill the requirement for HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (estrogen receptor \[ER\], progesterone receptor \[PgR\]) as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines (Hammond et al. 2010).
6. To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization (ISH) as defined in the relevant ASCO/CAP guidelines (Wolff et al. 2013).
7. Have locally advanced recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
8. Indication for endocrine based therapy in the metastatic setting
9. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
10. If central nervous system (CNS) metastases are known these have to be stable (radiotherapy finished for more than 14 days ago, no required steroid medication with more than 4 mg Dexamethasone per day)
11. Pre- and postmenopausal patients are allowed. Postmenopausal is defined as no menses for 12 months without an alternative medical cause. Women of Childbearing Potential (WOCBP, defined as not postmenopausal and not surgically or congenitally sterile) whose male partners are potentially fertile (e.g. no vasectomy) must use highly effective contraception methods for the duration of the trial and for at least 3 weeks after last dose of drugs used in the trial.Women of childbearing potential must use highly effective contraception methods for two years after the last dose of fulvestrant. Highly effective birth control methods that results in a failure rate of less than 1% per year include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner. Sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the patient.
12. No prior therapy for metastatic disease (except for first line endocrine therapy for maximal 3 months prior to start of abemaciclib therapy and if no progress occurred before study entry)
13. Previous adjuvant endocrine therapy and (neo)adjuvant chemotherapy is allowed
14. Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or ≤ Grade 2 peripheral neuropathy prior to registration. A washout period of at least 21 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy).
15. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and registration.
16. One of the following as defined by the RECIST v1. 1 (see Attachment 15.5):
1. Measurable disease. At least one measurable lesion assessable using standard techniques by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1). Tumor evaluation according to RECIST version 1.1 (based on local assessment) has to be performed within 28 days before trial registration.
2. Nonmeasurable bone-only disease (must be evaluable, but not necessarily measurable by RECIST). Nonmeasurable bone-only disease may include any of the following: blastic bone lesion, lytic bone lesions without a measurable soft tissue component, or mixed lytic-blastic bone lesions without a measurable soft tissue component.
17. The patient has adequate bone marrow and organ function evidenced by the following laboratory results: absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelet count ≥ 100 × 109/L, Hemoglobin ≥ 8 g/dL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × ULN (≤ 3 x ULN in case of liver metastases), Total Bilirubin ≤ 1.5 × ULN (with Gilbert's syndrome max. 2 x ULN), Serum Creatinine ≤ 2.0 mg/dl or 177µmol/L, Coagulation: International Normalized Ratio (INR) ≤ 1,5
18. The patient is able to swallow oral medications
19. Willingness to use the provided CANKADO digital health application to report side effects and patient reported outcomes (The use of the CANKADO app is not mandatory for study participation, but is strongly recommended)
20. Negative pregnancy test before trial registration for women of child-bearing potential and highly effective contraception if the risk of conception exists and a negative serum pregnancy test within 7 days after the first dose of trial treatment. Pregnancy tests should be performed in premenopausal patients according to local standard
Exclusion Criteria
1. Visceral crisis or life expectancy \< 6 months
2. History of hypersensitivity reactions attributed to Abemaciclib or to other components of drug formulation
3. Prior treatment with chemotherapy in the metastatic setting or endocrine therapy in the metastatic setting (except for first line endocrine therapy in metastatic or locally advanced disease for maximal 3 months prior to start of abemaciclib therapy and if no progress occurred before study entry)
4. Patient not eligible for endocrine based therapy
5. Any concurrent severe, uncontrolled systemic disease, social or psychiatric condition that might interfere with the planned treatment and with the patient's adherence to the protocol
6. The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this trial (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], 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 baseline Grade 2 or higher diarrhea).
7. Prior treatment with a CDK4/6 inhibitor for metastatic or locally advanced disease (first-line treatment with a CDK 4/6 inhibitor (Ribociclib/Palbociclib) in the metastatic setting is allowed only if terminated due to toxicity after max 3 months and no progression occurred before study entry. Prior treatment with a CDK 4/6 inhibitor in the neo-/adjuvant setting is allowed.)
8. 8\. Treatment with any other investigational agents within four weeks or 5 half-lives prior to trial registration, whichever is longer
9. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
10. Females who are pregnant or lactating
11. Legal incapacity or limited legal capacity
12. History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
13. The patient has active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating trial treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
14. Prior systemic anti-cancer therapy within the last 21 days prior to start of trial treatment except for first-line endocrine therapy in metastatic or locally advanced disease (see above)
15. Radiotherapy within the last 14 days prior to registration
16. Patient has had major surgery within 14 days prior to trial registration.
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Prof. Wolfgang Janni
OTHER
Responsible Party
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Prof. Wolfgang Janni
Director of the Department of Obstetrics and Gynecology
Principal Investigators
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Brigitte Rack, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Gynecology and Obstetrics, University Hospital Ulm, Germany
Locations
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Kliniken Ostalb gkAöR
Aalen, , Germany
Klinikum St. Marien Kommunalunternehmen - AöR Der Stadt Amberg
Amberg, , Germany
Klinikum Aschaffenburg-Alzenau gGmbH
Aschaffenburg, , Germany
Gemeinschaftspraxis Dr. Heinrich / Dr. Bangerter
Augsburg, , Germany
Universitätsklinikum Augsburg A.d.ö.R
Augsburg, , Germany
MediOnko-Institut GbR
Berlin, , Germany
Hämatologikum Biberach
Biberach, , Germany
Gynäkologisches Zentrum Bonn - Friedensplatz
Bonn, , Germany
Studien GbR Braunschweig
Braunschweig, , Germany
Hämato-Onkologische Praxis im Medicum
Bremen, , Germany
St. Elisabeth-Krankenhaus GmbH
Cologne, , Germany
Onkologisches Zentrum Donauwörth
Donauwörth, , Germany
Gemeinschaftspraxis
Dresden, , Germany
Onkozentrum Dresden
Dresden, , Germany
MVZ Medical Center Düsseldorf GmbH
Düsseldorf, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Internistische Praxis Ehingen
Ehingen, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
St. Antonius-Hospital
Eschweiler, , Germany
Centrum für Hämatologie und Onkologie Bethanien
Frankfurt, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Krankenhäuser Landkreis Freudenstadt gGmbH
Freudenstadt, , Germany
Internistische Gemeinschaftspraxis
Friedrichshafen, , Germany
Klinikum Garmisch-Partenkirchen GmbH
Garmisch-Partenkirchen, , Germany
Main-Kinzig-Kliniken gGmbH Gelnhausen
Gelnhausen, , Germany
Gemeinschaftspraxis und Tagesklinik Halle
Halle, , Germany
Albertinen-Krankenhaus
Hamburg, , Germany
Sana Klinikum Hameln-Pyrmont
Hamelin, , Germany
Frauenärzte am Bahnhofsplatz
Hildesheim, , Germany
ViDia Christliche Kliniken Karlsruhe
Karlsruhe, , Germany
Klinikum Kassel GmbH
Kassel, , Germany
Klinikverbund Kempten-Oberallgäu gGmbH
Kempten, , Germany
Klinikum Konstanz
Konstanz, , Germany
ZAGO- Zentrum für ambulante gynäkologische Onkologie
Krefeld, , Germany
Krankenhausgesellschaft St. Vincenz mbH
Limburg, , Germany
Praxis für gynäkologische Onkologie / Prof. Dr. med. Ulrike Nitz / Raquel von Schumann
Mönchengladbach, , Germany
Kliniken Ostalb gkAöR, Stauferklinikum Schwäbisch Gmünd
Mutlangen, , Germany
LMU - Klinikum der Universität München
München, , Germany
München Klinik gGmbH Harlaching
München, , Germany
TZN-Tumorzentrum Niederrhein GmbH
Neuss, , Germany
Klinikum Nürnberg Nord
Nuremberg, , Germany
medius KLINIK NÜRTINGEN
Nürtingen, , Germany
Praxis Dr. Guth
Plauen, , Germany
Klinikum Ernst von Bergmann gGmbH
Potsdam, , Germany
Klinikum Rheine
Rheine, , Germany
GPR Gesundheits- und Pflegezentrum Rüsselsheim gGmbH
Rüsselsheim am Main, , Germany
Diakoneo Diak-Klinikum Schwäbisch Hall gGmbH
Schwäbisch Hall, , Germany
Clinical Research Stolberg GmbH
Stolberg, , Germany
Gynäkologie Kompetenzzentrum Stralsund
Stralsund, , Germany
Universitätsfrauenklinik Tübingen
Tübingen, , Germany
University Hospital Ulm Gynecology/Obstetrics
Ulm, , Germany
St. Josefs-Hospital
Wiesbaden, , Germany
Spital Wallis
Brig, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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2021-000287-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MINERVA
Identifier Type: -
Identifier Source: org_study_id
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