A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GB

• Status: Recruiting
• Trial end date: 2023-03-31

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.

• Phase: Phase 4

Details

• Lead Sponsor: German Breast Group
• Collaborators: Advanced Medical Services; AMS Advanced Medical Services GmbH; Pfizer; Philips Respironics
• Treatments: Capecitabine; Epirubicin; Exemestane; Fulvestrant; Hormones; Letrozole; Paclitaxel; Palbociclib; Tamoxifen; Vinorelbine