Metadata supporting data files of the related article: Randomized Phase-II Evaluation of Letrozole Plus Dasatinib in Hormone Receptor Positive Metastatic Breast Cancer Patients
Creators: name: Paul, Devchand
name: Vukelja, Svetislava J.
name: Holmes, Frankie Ann
name: Blum, Joanne L.
name: McIntyre, Kristi J.
name: Lindquist, Deborah L.
name: Osborne, Cynthia R.
name: Sanchez, Ines J.
name: Goldschmidt, Jerome H.
name: Wang, Yunfei
name: Asmar, Lina
name: Strauss, Lewis
name: O’Shaughnessy, Joyce
Publisher: name: figshare
Year: 2019
Subjects: Cancer
Medicine
Cancer Cell Biology
Chemotherapy
Oncology and Carcinogenesis not elsewhere classified

description: This randomized non-comparative phase II study with a concurrent control arm was designed to evaluate the efficacy and safety of dasatinib plus letrozole for postmenopausal patients with Estrogen receptor (ER)-positive, Human epidermal growth factor receptor (HER2)-negative metastatic breast cancer (MBC), and to determine if this combination could delay the development of endocrine therapy resistance. <br><b>Data access:</b> The datasets supporting the figures, tables and supplementary figures and tables in this published article are not publicly available in accordance with the policy of US Oncology Research, LLC, and the informed consents signed by the patients. Data supporting the figures, tables and supplementary figures, can be accessed from the Vice President of US Oncology Research, Dr. Sandy Smith, email address: <b>Sandy.smith1@mckesson.com</b> on request. The data supporting the supplementary tables in the published article are not available from the US Oncology Research as these data were provided by the Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (Theranostics Health; Rockville, MD) that performed the experiments.<br><br><b>Study approval: </b>A US Oncology Institutional Review Board (IRB) reviewed and approved the protocol and all participating patients signed an IRB approved informed consent form.<br><b>Study aims and methodology:</b><br>This study investigated whether adding the Src kinase inhibitor dasatinib to aromatase inhibitor (AI) therapy improved outcomes in estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer (MBC).The primary objective of this study was to determine clinical benefit rate (CBR; complete response + partial response + stable disease ≥6 months) with letrozole plus dasatinib or letrozole monotherapy. Secondary objectives included overall response rates (ORR), median progression-free survival (PFS), 6- and 12-month PFS rates, overall survival (OS), changes in bone mineral density (BMD) from baseline to on-study assessment, safety, and evaluation of potential biomarkers to predict sensitivity and/or resistance to dasatinib. Postmenopausal patients with ER-positive, HER2-negative MBC (0-1 prior chemotherapies and no prior AI therapy for MBC) were eligible for this non-comparative, parallel group, phase II study. Patients were randomized to letrozole (2.5 mg/day Per os (PO)) alone or with dasatinib (100 mg/day PO). Patients with disease progression on letrozole alone could cross over to dasatinib plus continued letrozole. The primary endpoint was clinical benefit rate (CBR; complete response + partial response + stable disease ≥6 months). A total of 120 patients were randomized.<br><b>Dataset description:</b><b><br></b><b>Data supporting figure 2:</b> Data set <b>Survivalcrossover.sas7bdat </b>is in <b>SAS file format</b> and includes progression-free survival data in the intent-to-treat population. <br><b>Data supporting figure 3:</b> Datasets <b>Survivalcrossover.sas7bdat</b>, <b>Dhx.sas7bdat</b>, <b>Priors.sas7bdat</b> and <b>Metsites.sas7bdat</b> are all in <b>SAS file format</b> and include data used to create a forest plot of hazard ratios for progression-free survival by population subgroups.<br><b>Data supporting table 1:</b> Datasets <b>Demog.sas7bdat, Dhx.sas7bdat</b>, <b>Priors.sas7bdat</b>, <b>Metsites.sas7bdat </b>and <b>Vitals.sas7bdat </b>are in <b>SAS file format</b> and contain demographics and baseline characteristics of the intent-to-treat population.<br><b>Data supporting table 2:</b> Dataset <b>Ae.sas7bdat</b> is in <b>SAS file format </b>and contains data on the adverse events occurring in &gt;10% of Patients on Study Treatment.<br><b>Data supporting supplementary figure 1</b>: Datasets <b>Bonedensity.sas7bdat</b>, <b>Demog.sas7bdat</b> and <b>Survivalcrossover.sas7bdat </b>are in <b>SAS file format</b> and contain data on the bone mineral density T scores of the patients in the Letrozole and the Letrozole + Dasatinib intent to treat groups.<br><b>Software needed to
access data: </b>All the datasets supporting the figures and tables in this
published article are in SAS file format and require the SAS statistical
software to be accessed. <br><br><br>