Metadata record for the article: Capivasertib, a selective AKT kinase inhibitor, in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer: a non-randomized controlled trial
Creators: name: Smyth, Lillian M
name: Batist, Gerald
name: Meric-Bernstam, Funda
name: Kabos, Peter
name: Spanggaard, Iben
name: Lluch, Ana
name: Komal Jhaveri
name: Varga, Andrea
name: Wong, Andrea
name: Schram, Alison M.
name: Ambrose, Helen
name: T. Hedley Carr
name: De Bruin, Elza C
name: Salinas-Souza, Carolina
name: Foxley, Andrew
name: Hauser, Joana
name: Lindemann, Justin PO
name: Maudsley, Rhiannon
name: McEwen, Robert
name: Moschetta, Michele
name: Myria Nikolaou
name: Schiavon, Gaia
name: Pedram Razavi
name: Banerji, Udai
name: Baselga, José
name: Hyman, David M.
name: Sarat Chandarlapaty
Publisher: name: figshare
Year: 2021
Subjects: subject: 111299 Oncology and Carcinogenesis not elsewhere classified
subject: FOS: Clinical medicine
subject: FOS: Clinical medicine
subject: 111203 Cancer Genetics
subject: 111502 Clinical Pharmacology and Therapeutics

description: This metadata record provides details of the data supporting the claims of the related article: “Capivasertib, a selective AKT kinase inhibitor, in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer: a non-randomized controlled trial”. The primary aim of the related study was to assess the safety and tolerability of capivasertib and fulvestrant in patients with <i>PTEN</i>-mutant, estrogen-receptor-positive metastatic breast cancer. A secondary aim of the study was to describe genomic biomarker analyses in the collected circulating tumor DNA and tumor samples. Type of data: Phase I trial data on drug efficacy, safety and tolerability; tumour raw sequencing data, Subject of data: Patients with <i>PTEN</i>-mutant, estrogen-receptor-positive metastatic breast cancer Sample size: 32 patients Population characteristics: Characteristics of the patients, including medical history and disease characteristics at baseline were collected. For example, age, gender, race, WHO performance status, visceral disease, estrogen and progesterone receptor status, HER2 status, prior anticancer regimens, prior CDK4/6 inhibitors, prior mTOR inhibitors, prior PI3K inhibitors, and smoking history. Recruitment: Upon screening patients’ tumours for mutations, patients with advanced or metastatic ER+ breast cancer that is positive for selected PTEN mutations were recruited. This includes two cohorts of patients: patients with prior fulvestrant treatment and those without. Date of data collection: Data cut-off date was June 2019 Geographic location: Patients were enrolled across eight recruitment sites in six countries Trial registration number: NCT01226316 <b>Data access</b> The raw sequencing data is not publicly available due to data privacy regulations and restrictions for use of such data as stated in the study protocol and patient consent form.<br> Individual-level data can potentially be accessed via a collaborative agreement with AstraZeneca Group. The clinical dataset analysed, including progression-free survival and tumour response data, is available and may be obtained in accordance with AstraZeneca’s data sharing policy as part of an external collaborative request (https://astrazenecagroup-dt.pharmacm.com//DT/Home/Index/) or an external data access request (https://vivli.org/ourmember/astrazeneca/). All aggregated genomic data required for the interpretation of the PTEN results can be found Figure 3 and Supplementary Figure 2 of the related manuscript. <b>Corresponding authors for this study</b> Sarat Chandarlapaty (ChandarS@mskcc.org) Juliet Fawcett (Juliet.Fawcett@mudskipper.biz) <br> <b>Study approval </b> All patients provided written informed consent and the institutional review boards or independent ethics committees of all investigational sites approved the protocol.