MADELINE is a multicenter study enrolling women with advanced/metastatic breast cancer (ABC/MBC) receiving palbociclib in combination with an aromatase inhibitor (AI) as initial endocrine therapy or fulvestrant after progression on prior endocrine therapy according to the FDA-approved indication for palbociclib (Group 1) or approved therapies for ABC/MBC other than palbociclib (Group 2). A novel mobile application was developed to collect real-time PRO data to assess patient (pt) functioning and quality of life through daily, weekly, and monthly questionnaires for 6 months. Patient demographic and clinical information was recorded in an electronic case report form at baseline and for the planned 6-month follow-up.
Patients were administered the 12-Item Short Form Health Survey (SF-12) and the Center for Epidemiologic Studies Depression Scale (CES-D-10) at baseline. An analysis of baseline data as of March 1, 2018, on Group 1 pts with baseline mobile app and electronic case report form data was performed.
Thirteen sites contributed 50 pts for this baseline analysis. Mean (SD) age was 58.6 (11.48); 86% were white. The most common metastatic sites were bone (54%) and lymph nodes (32%). ECOG performance status was 0, 1, and 2 in 61%, 24%, and 2% of pts, respectively. At enrollment, 27 pts (54%) initiated palbociclib plus AI, and 23 (46%) initiated palbociclib plus fulvestrant. There were no substantial differences between these palbociclib subgroups on SF-12 domain scores or CES-D-10 score; overall cohort scores are shown in the table.
This initial analysis describes the current population of palbociclib-treated pts in the MADELINE study. Recruitment and data collection are ongoing with plans for 30 total sites and up to 250 patients, with final results expected August 2019.Table: 356P
|Measure Mean (SD)||Group 1 (N = 50)|
|General Health||46.7 (9.51)|
|Physical Functioning||45.4 (11.07)|
|Role Physical||44.3 (11.46)|
|Bodily Pain||45.1 (12.96)|
|Social Functioning||47.2 (10.83)|
|Role Emotional||47.3 (9.76)|
|Mental Health||48.8 (10.73)|
|Physical Component Summary||44.4 (11.65)|
|Mental Component Summary||48.7 (10.53)|
Clinical trial identification
Legal entity responsible for the study
D. Odom, K. Hollis, D. Richardson, J.A. Kaye: Employee: RTI Health Solutions, who were paid consultants to Pfizer in connection with the development of this abstract. D. Mitra, L. McRoy: Employment and stock ownership: Pfizer.