Status:
TERMINATED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Breast Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic dist...
Detailed Description
The purpose of this open-label, single arm, multi-center, Phase II interventional pilot trial was to evaluate if a decentralized clinical trial (DCT) using a telemedicine platform offers a satisfactor...
Eligibility Criteria
Inclusion
- Key
- 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 was willing to operate a smartphone compatible with the software of the medical device and willing to manage applications
- Participant was willing to use the telemedicine platform and to follow the remote participant monitoring procedure.
- Key
Exclusion
- Participant had 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 was longer.
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04862143
Start Date
March 8 2022
End Date
September 19 2022
Last Update
June 20 2024
Active Locations (1)
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1
Novartis Investigative Site
Örebro, Sweden, 701 85