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

Phase 1

• Conditions: HR-positive/HER2-negative advanced breast cancer with a PIK3CA mutation; MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005882-15-SE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-17
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: • To explore patient retention on DCT approach<br>• To explore if the DCT approach ensures safe and suitable remote management of patients<br>• Patient compliance to treatment<br>• To assess adverse events (AEs) of special interest (AESIs) and AEs leading to in-clinic visits<br>• To evaluate participant-reported global health status, quality of life (QOL) and pain<br>• To assess the effectiveness of alpelisib plus fulvestrant<br>;Primary end point(s): Participant satisfaction, assessed at the start of the trial, every 12 weeks, and at the end of trial through the Trial Feedback Questionnaire (TFQ);Timepoint(s) of evaluation of this end point: at the start of the trial, every 12 weeks, and at the end of trial;Main Objective: To assess participant satisfaction with the DCT experience