69TiP - MADELINE Asia: A mobile app-based prospective observational study of patient reported outcomes in advanced breast cancer in Asia

Background

The incidence of breast cancer in Asia is rising. Recent advances in hormone receptor (HR) positive and human epidermal growth factor receptor negative advanced breast cancer (aBC) includes introduction of the CDK 4/6 inhibitors. Palbociclib was the first drug in this class to be introduced in Asia and is approved for use in aBC in combination with aromatase inhibitors (P+AI) as initial endocrine based therapy in postmenopausal women or with fulvestrant (P+F) in women with disease progression following endocrine therapy. Globally, there has been evaluations in the real world setting for palbociclib. However, data published for Asian patients in this setting remains scarce.

Trial design

Study Design: A prospective, observational, non-interventional, multi-centre study. A smartphone-based mobile application to collect patient-reported outcomes (PROs) associated with aBC and its treatment on Palbociclib has been developed. The impact of aBC and associated treatment of symptoms, functioning and quality of life (QOL) as reported by patients will be studied. Clinical data on therapy management, occurrence of neutropenia and any association between neutropenia, quality of life and PROs will also be captured. Eligibility Criteria: Women with HR+/HER2– aBC receiving P+AI or P+F as per approved indication in their country. Aims and Objectives: Primary objectives are to assess and describe clinical and PROs in eligible patient population. 12-Item ‘Short Form Health Survey’ & ‘Center for Epidemiological Studies Depression Scale’ would be used. The study will also document changes in therapy as well as the incidence, severity, and duration of neutropenia through data recorded from patient’s medical records. Statistical Methods: For the purpose of this study, analyses will generally be descriptive in nature and will be conducted using SAS statistical software Present Accrual and Target Accrual: Approximately 100 patients from up to 12 sites within 4 Asian countries (Taiwan, India, Malaysia and Hong Kong) will be enrolled. Study duration will be approximately 12 months assuming 6 months of recruitment. The study is open in all 4 participating countries with 7 patients recruited so far.

Clinical trial identification

Legal entity responsible for the study

Pfizer Inc.

Funding

Pfizer Inc.

Disclosure

M. Singh, J. Binko, M. Alam: Shareholder/Stockholder/Stock options, Full/Part-time employment: Pfizer Inc. K. Lilly, S. Chang: Full/Part-time employment: Parexel International Pty Ltd. S. Bowles: Full/Part-time employment: Intouch Solutions. All other authors have declared no conflicts of interest.