Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant

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 - Fulvestrant TELEPIK Trial

ClinicalTrials.gov Identifier: NCT04862143

Novartis Reference Number: CBYL719A03201

Last Update: Apr 05, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The study is designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.

Condition 
Advanced Breast Cancer
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Mar 08, 2022
Completion date 
Jul 31, 2023
Gender 
All
Age(s)
18 Years - 99 Years (Adult, Older Adult)

Interventions

Drug
Alpelisib
Alpelisib 300 mg daily up to 12 cycles of 28 days each
Drug
fulvestrant
fulvestrant 500 mg administered intramuscularly on Cycle 1, Day 1 and Cycle 1, Day 15, and on Day 1 of each cycle thereafter until Cycle 12.

Eligibility Criteria

Inclusion Criteria:

Participant is an adult ≥18 years old at the time of consent
Participant with ABC (loco regionally recurrent or metastatic) not amenable to curative therapy.
Participant with a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PR-positive breast cancer by local laboratory.
Participant with a confirmed HER2-negative ABC.
Participant with a pathology report confirming PIK3CA mutant status by a certified laboratory using a validated PIK3CA mutation assay (from either tissue or blood).
Participant is a man or a pre- or post-menopausal woman.
Participant is willing to operate a smartphone compatible with the software of the medical device and willing to manage applications
Participant is willing to use the telemedicine platform and to follow the remote participant monitoring procedure.
Participant has signed an informed consent form before any trial

Exclusion Criteria:

Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor.
Participant with known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant.
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.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

Sweden
Novartis Investigative Site
Recruiting
Orebro, 701 85
-
Sweden

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]