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
Have given written informed consent prior to any trial-specific procedures
Are reliable, willing to be available for the duration of the trial and are willing to follow trial procedures
Are female and aged ≥ 18 years
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.
Visceral crisis or life expectancy < 6 months
History of hypersensitivity reactions attributed to Abemaciclib or to other components of drug formulation
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)
Patient not eligible for endocrine based therapy
Parallel
Abemaciclib + Aromatase Inhibitor
DrugAbemaciclib 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
DrugAbemaciclib 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)
Progression Free Survival (PFS)
PFS, defined as the time from date of trial registration until progressive disease (PD) or death from any cause, whichever comes first (as defined by RECIST guideline version 1.1). If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.
Adverse Events
Adverse Events assessed by investigator (type, frequency, severity (graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0)), seriousness)
Patient-reported side effects
Additional capture of Patient-Reported side effects on a daily basis via CANKADO PRO-React (patient diary).
Patient-reported global health status
Daily self-assessment of global health status using the visual analogue scale (EQ-VAS, based on the EQ-5D questionnaire) via CANKADO. The EQ-VAS scale ranges from 0 (the worst possible health status to 100 (the best possible health status).
Frequency of hospitalizations
Frequency of hospitalizations during study treatment
Click on the lead sponsor to view all of their trials.
Prof. Wolfgang Janni
Lead sponsor
University of Ulm
Sponsor institution
Eli Lilly and Company
Collaborator
