Abstract 69TiP
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.
Resources from the same session
105P - Prospective, open-label, observational study of cetuximab for metastatic colorectal carcinoma (mCRC): The OPTIM1SE study
Presenter: Tsai-Sheng Yang
Session: e-Poster Display Session
106P - Efficacy and tolerability of capecitabine and mitomycin-C based concurrent radiotherapy in patients with anal canal cancer
Presenter: Prabhat Bhargava
Session: e-Poster Display Session
107P - Safety and efficacy of trifluridine/tipiracil (FTD/TPI) in previously treated metastatic colorectal cancer (mCRC): Results from the Australian cohort of the phase IIIb, international, open-label, early-access PRECONNECT study
Presenter: Timothy Price
Session: e-Poster Display Session
108P - Comparative analysis of two-stage hepatectomy and enhanced one-stage hepatectomy in the setting of bilobar colorectal liver metastases
Presenter: Hayk Torgomyan
Session: e-Poster Display Session
109P - Efficacy and safety of biweekly or triweekly XELOX regimen for adjuvant chemotherapy of colorectal cancer
Presenter: hangyu zhang
Session: e-Poster Display Session
110P - Analysis for stereotactic body radiotherapy (SBRT) effect for colorectal liver metastases
Presenter: Wei Zou
Session: e-Poster Display Session
111P - A meta-analysis study on safety and effectiveness comparison between FOLFOX and XELOX regiments on advanced stage colorectal cancer
Presenter: Ida Bagus Budhi
Session: e-Poster Display Session
112P - Pembrolizumab vs chemotherapy in patients with microsatellite instability-high/mismatch repair deficient metastatic colorectal cancer: Asia subgroup results of the phase III KEYNOTE-177 study
Presenter: Takayuki Yoshino
Session: e-Poster Display Session
122P - Nomogram to predict short-term effect of radiotherapy based on pre/post-treatment inflammatory biomarkers and their dynamic changes in esophageal squamous cell carcinoma
Presenter: Shuai Liang
Session: e-Poster Display Session
123P - The clinical value of prognostic nutritional index in esophagogastric junctional adenocarcinoma patients with anastomotic leakage after surgery
Presenter: Yan Wang
Session: e-Poster Display Session