Trials / Recruiting
RecruitingNCT05362760
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
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 - A Phase IV Trial
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Prof. Wolfgang Janni · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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) |
| DRUG | 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) |
Timeline
- Start date
- 2022-04-27
- Primary completion
- 2029-04-01
- Completion
- 2029-04-01
- First posted
- 2022-05-05
- Last updated
- 2025-05-16
Locations
54 sites across 2 countries: Germany, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05362760. Inclusion in this directory is not an endorsement.