Open-label, multicenter, pilot-trial evaluating the safety and utility of a hybrid decentralized clinical trial (DCT) approach using a TELEmedicine platform in patients with HR-positive/HER2-negative advanced breast cancer with a PIK3CA mutation treated with alpelisib – fulvestrantTELEPIK Trial - TELEPIK – Telemedicine with PIK3CA inhibitor

ovartis Pharma AG0 个研究点目标入组 20 人开始时间: 2021年3月17日最近更新: 2021年7月12日

研究概览

暂无简介。

•1. Participant is an adult =18 years old at the time of consent
•2. Participant with ABC (loco regionally recurrent or metastatic) not amenable to curative therapy.
•3. Participant with a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PR-positive breast cancer by local laboratory.
•4. Participant with a confirmed HER2-negative ABC.
•5. Participant with a pathology report confirming PIK3CA mutant status by a certified laboratory using a validated PIK3CA mutation assay (from either tissue or blood).
•6. Participant is a man or a pre- or post-menopausal woman.
•7. Participant is willing to operate a smartphone compatible with the software of the medical device and willing to manage applications
•8. Participant is willing to use the telemedicine platform and to follow the remote participant monitoring procedure.
•9. Participant has signed an informed consent form before any trial related activities and according to local guidelines.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1. Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor.
•2. Participant with known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant.
•3. Participant participated in a prior investigational study within 30 days prior to the start of trial treatment or within 5 half-lives of the trial treatment, whichever is longer.

发起方