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).

PHASE4CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

March 1, 2018

Primary Completion Date

August 30, 2024

Study Completion Date

August 30, 2024

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)

Drug intervention

Trial Locations (1)

60431

Agaplesion Markus Krankenhaus - Klinik für Gynäkologie und Geburtshilfe, Frankfurt am Main

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

AMS Advanced Medical Services GmbH

INDUSTRY

lead

GBG Forschungs GmbH

OTHER