PERFORM: a non-interventional study assessing the patients' treatment starting with 1L palbociclib in HR+/HER2- ABC.
Michael Patrick LuxEva Diana RunkelEsther GlastetterCorinne VannierJohanna BunckeMelanie FrankRupert BartschMarc ThillAchim WöckelPublished in: Future oncology (London, England) (2022)
The prospective, non-interventional PERFORM study describes and analyzes the effectiveness of palbociclib in combination with endocrine therapy (aromatase inhibitor or fulvestrant) as first-line treatment for patients with locally advanced or metastatic HR+/HER2- breast cancer in the real-world setting in Germany and Austria. PERFORM will reflect current patient characteristics and routine treatment patterns including treatment sequences and time to subsequent (chemo)therapy. Besides, second-line treatment effectiveness and patient-relevant end points such as longitudinal patient-reported outcome measurements beyond disease progression will be analyzed. Accounting for the heterogenous real-world patient population, data on clinicopathologic subgroups underrepresented in clinical trials such as elderly or male will be analyzed. Taken together, PERFORM will close knowledge gaps from clinical trials in real world.
Keyphrases
- clinical trial
- squamous cell carcinoma
- patient reported outcomes
- randomized controlled trial
- locally advanced
- end stage renal disease
- stem cells
- combination therapy
- chronic kidney disease
- case report
- electronic health record
- radiation therapy
- drug delivery
- lymph node
- newly diagnosed
- artificial intelligence
- big data
- peritoneal dialysis
- cancer therapy