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

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 di

Trial Details

NCT ID
NCT05362760
Phase
PHASE4
Sponsor
Prof. Wolfgang Janni
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Abemaciclib + Aromatase Inhibitor
  • Abemaciclib + Fulvestrant
Locations (sample)
  • Aalen, Germany|48.83777,10.0933
  • Amberg, Germany|49.44287,11.86267
  • Aschaffenburg, Germany|49.97704,9.15214
  • Augsburg, Germany|48.37154,10.89851
  • Berlin, Germany|52.52437,13.41053

Key Eligibility Criteria

  • Patients will be included in the trial only if they meet all the following criteria:
  • 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

For full eligibility, visit ClinicalTrials.gov.

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