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Clinical Trial Summary

The goal of the study for patients with metastatic breast cancer (MBC) is to show that palbociclib + endocrine therapy shows a significant improvement in time-to-treatment failure over chemotherapy regimen (mono-chemotherapy with or without endocrine therapy). This would provide level 1 evidence from real world that palbociclib plus endocrine therapy is the first choice in MBC patients needing first-line therapy not only compared to endocrine therapy but also compared to chemotherapy with or without endocrine maintenance therapy. In addition, we assume that patient-reported outcome as measured by FACT-B and a novel composite endpoint of well-being and healthcare utilization (DMTI) will be improved with palbociclib + endocrine treatment vs. chemotherapy regimen.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03355157
Study type Interventional
Source German Breast Group
Contact Konstantin Reißmüller
Phone 49-6102-7480
Email konstantin.reissmueller@gbg.de
Status Recruiting
Phase Phase 4
Start date March 1, 2018
Completion date March 31, 2023

See also
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