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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
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511209-49-00
Enrollment
285
Registered
2024-08-30
Start date
2022-04-26
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with hormone receptor positive HER2 negative locally advanced or metastatic breast cancer

Brief summary

The primary endpoint of this trial is progression-free survival (PFS). PFS time is measured from trial registration until the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause. Patients who have neither progressed nor died will be censored at the day of their last radiographic tumor assessment, if available, or date of trial registration if no post-initiation (that is, post-baseline) radiographic assessment is available.

Detailed description

Overall Survival (OS), Objective Response Rate (ORR), Clinical Benefit Rate (CBR)

Interventions

DRUGLETROZOLE
DRUGEXEMESTANE
DRUGANASTROZOLE
DRUGFULVESTRANT

Sponsors

Universitaetsklinikum Ulm AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this trial is progression-free survival (PFS). PFS time is measured from trial registration until the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause. Patients who have neither progressed nor died will be censored at the day of their last radiographic tumor assessment, if available, or date of trial registration if no post-initiation (that is, post-baseline) radiographic assessment is available.

Secondary

MeasureTime frame
Overall Survival (OS), Objective Response Rate (ORR), Clinical Benefit Rate (CBR)

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026