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 (TELEPIK)

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    20
  • sponsor
    Novartis Pharmaceuticals
Updated on 26 April 2022

Summary

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.

Description

Open-label, single arm, multi-center, Phase II interventional pilot trial. Primary objective will be to assess participant satisfaction with the decentralized clinical trial (DCT) experience.

The trial will enroll men and pre- and post-menopausal women with a HR-positive/HER2-negative ABC (loco regionally recurrent not amenable to curative therapy or metastatic) with a PIK3CA mutation, which progressed on or after endocrine-based treatment.

Participants will receive alpelisib 300 mg daily and 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.

Pre-menopausal women will receive goserelin 3.6 mg on Day 1 of each cycle.

Details
Condition Advanced Breast Cancer
Treatment fulvestrant, Alpelisib
Clinical Study IdentifierNCT04862143
SponsorNovartis Pharmaceuticals
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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