A Post Marketing Surveillance on Piqray in Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Piqray.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Post Marketing Surveillance on Piqray (Alpelisib) in Korea
Overview
This is a prospective, multicenter, open-label, non-comparative, non-interventional, observational study to assess te safety and effectiveness of Piqray in the real-world setting
Detailed description
The observation duration will be up to 24 weeks after enrollment, which is sufficient to provide adequate information about the safety and effectiveness of Piqray. If the subject does not return for a follow-up visit or stops taking Piqray for any reason, all data collected until the date of the last contact of the subject will be used. Patients will be followed up (safety follow up) for 30 days afetr either 24 weeks-treatment or early withdrawal.
Interventions
- Other Piqray
There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.
Primary outcome measures
- Incidence of AEs [Time frame: 24 weeks]
Secondary outcome measures (2)
- Objective response rates (ORRs) [Time frame: Up to 24 weeks]
- Prescription dose of Piqray in combination with fulvestrant [Time frame: Up to 24 weeks]
Eligibility criteria
Inclusion criteria
Subjects eligible for this study must meet all of the following criteria:
- Postmenopausal women and men who have a confirmed diagnosis of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer.
- Patients who have progressed on prior endocrine based therapy and are going to start Piqray treatment for the first time in accordance with the locally approved label.
- Patients who are willing to provide written informed consent
Exclusion criteria
Subjects eligible for this study must not meet the following criteria:
- Patients with contraindication according to prescribing information for Piqray in Korea.
\- Severe hypersensitivity to Piqray or to any of its components
- Female subjects who are pregnant and nursing (lactating)
- Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray.
- Participants who receive or are going to receive any investigational medicine during surveillance period.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 19 centers
- Novartis Investigative Site — Cheonan Si
- Novartis Investigative Site — Daegu
- Novartis Investigative Site — Goyang-si
- Novartis Investigative Site — Suwon
- Novartis Investigative Site — Gyeonggi-do
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Seoul
- … and 11 more centers
Identifiers
NCT: NCT05293470 · CBYL719CKR01