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).

Sponsor
GBG Forschungs GmbH
Study ID
NCT03355157
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 1, 2018
Status verified
Sep 2024
Primary completion
Aug 30, 2024
Completion
Aug 30, 2024

Study Design

Enrollment
130 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Palbociclib + endocrine therapy
    Experimental arm for testing palbociclib + endocrine therapy.
  • Active Comparator: Chemotherapy +/- endocrine maintenance therapy
    Chemotherapy +/- endocrine maintenance as comparator arm.

Primary Outcome Measure

Time-to-treatment failure (TTF) [ Time Frame: 31 months ]

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