File(s) not publicly available
Reason: Data cannot be openly shared to protect participant privacy
Metadata record for the article: Selective AKT kinase inhibitor capivasertib in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer
This metadata record provides details of the data supporting the claims of the related article: “Selective AKT kinase inhibitor capivasertib in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer”.
The primary aim of the related study was to assess the safety and tolerability of capivasertib and fulvestrant in patients with PTEN-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 PTEN-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
Data access
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.
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.
Corresponding authors for this study
Sarat Chandarlapaty (ChandarS@mskcc.org)
Juliet Fawcett (Juliet.Fawcett@mudskipper.biz)
Study approval
All patients provided written informed consent and the institutional review boards or
independent ethics committees of all investigational sites approved the protocol.
