HR-positive/HER2-negative advanced breast cancer with a PIK3CA mutation MedDRA version: 21.1 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Piqray
Product Name: Piqray
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ALPELISIB
CAS Number: 1217486-61-7
Current Sponsor code: BYL719
Concentration unit: mg milligram(s)
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To explore patient retention on DCT approach • To explore if the DCT approach ensures safe and suitable remote management of patients • Patient compliance to treatment • To assess adverse events (AEs) of special interest (AESIs) and AEs leading to in-clinic visits • To evaluate participant-reported global health status, quality of life (QOL) and pain • To assess the effectiveness of alpelisib plus fulvestrant ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Endpoints for secondary objectives • Proportion of participants on remote monitoring at 3, 6, 12 months for participants still on treatment. Statistical assumptions (descriptive): targeted proportion of patients remaining on remaining on remote monitoring after 6 months, 75% Note: unscheduled in-clinic visit does not exclude for DCT monitoring • Total number of unscheduled in-clinic visits because of safety reasons • Total number of unscheduled in-clinic visits and the reason • Number of unscheduled in-clinic visits per participant in the study • Discontinuation rate related to adverse events Note: Visits initially planned to be performed remotely but finally performed on site and unscheduled visits on site or at the local oncologist practice will be considered as unscheduled in-clinic visits. Visits that require treating oncologists or district nurses assessments are considered unscheduled visits. • Overall compliance • Type, frequency and severity of AESIs (hyperglycemia, rash, and diarrhea) per Common Terminology Criteria for Adverse events (CTCAE) v4.03 (incidence proportion) • Number and proportion of AEs leading to in-clinic visits • Change in scores of participant reported outcome (PRO) questionnaire (within same participant) from baseline to each time point of questionnaire administration (every 12 weeks) • PFS according to RECIST 1.1;Timepoint(s) of evaluation of this end point: • Proportion of participants on remote monitoring at 3, 6, 12 months for participants still on treatment. The following will be monitored on an ongoing basis: • Total number of unscheduled in-clinic visits because of safety reasons • Total number of unscheduled in-clinic visits and the reason • Number of unscheduled in-clinic visits per participant in the study • Discontinuation rate related to adverse events • Overall compliance • Type, frequency and severity of AESIs • Number and proportion of AEs leading to in-clinic visits • Change | — |
Countries
Sweden
Contacts
Public ContactMedical information
Novartis Sverige AB
Outcome results
None listed