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 (GBG 93 - PADMA Study).
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.
Timeline
- Start
- 2018-03-01
- Primary completion
- 2024-08-30
- Completion
- 2024-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Epirubicin | Small molecule | — | — |
| Subject | Exemestane | Small molecule | — | — |
| Subject | Fulvestrant | Small molecule | — | — |
| Subject | Letrozole | Other / unclassified | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Subject | Palbociclib | Small molecule | — | — |
| Subject | Tamoxifen | Small molecule | — | — |
| Subject | Vinorelbine | Small molecule | — | — |