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.
Tom DegenhardtPeter A FaschingDiana LüftnerVolkmar MüllerChristoph ThomssenChristian SchemIsabell WitzelThomas DeckerHans TeschSherko KümmelChristoph UleerRachel WuerstleinOliver HoffmannMathias WarmNorbert MarschnerTimo SchinkötheRonald E KatesJohannes SchumacherBurkhard OtrembaMatthias ZaissNadia HarbeckMarcus Schmidtnull nullPublished in: Trials (2023)
The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = "Deterioration of quality of life" (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform). EudraCT Number: 2016-004191-22.
Keyphrases
- metastatic breast cancer
- patient reported outcomes
- end stage renal disease
- ejection fraction
- newly diagnosed
- chronic kidney disease
- locally advanced
- clinical trial
- double blind
- squamous cell carcinoma
- radiation therapy
- peritoneal dialysis
- open label
- phase iii
- phase ii
- stem cells
- randomized controlled trial
- cell therapy
- patient reported