Trial status
METASTATIC BREAST CANCER
PreCycle: Multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with Palbociclib and an aromatase inhibitor- or Palbociclib and Fulvestrant.Protocol Number: PH001PreCycle, Version 2.0AGOB002 TraFO002-16EudraCT Number: 2016–004191-22Testing Objective: eHealth-based Patient-Reported Outcome (ePRO)Study Treatment: Palbociclib in combination with endocrine therapy (aromatase inhibitor or / fulvestrant combined with a LHRH agonist in pre- or peri-menopausal women)Sponsor Name and Legal Registered Address:palleos healthcare GmbHTaunusstr. 5a65183 WiesbadenShort Title:Impact of eHealth-support on Quality of Life in metastatic breast cancer patients treated with Palbociclib and endocrine therapy.Approval of legal authority:Bundesamt für Arzneimittel und Medizinprodukte