Breast Cancer
Conditions
Keywords
Breast cancer, NIS, Piqray, Korea, Alpelisib
Brief summary
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
OTHERPiqray
There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Subjects eligible for this study must meet all of the following criteria: 1. 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. 2. 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. 3. Patients who are willing to provide written informed consent
Exclusion criteria
Subjects eligible for this study must not meet the following criteria: 1. Patients with contraindication according to prescribing information for Piqray in Korea. \- Severe hypersensitivity to Piqray or to any of its components 2. Female subjects who are pregnant and nursing (lactating) 3. Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray. 4. Participants who receive or are going to receive any investigational medicine during surveillance period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs | 24 weeks | Incidence of AEs, including SAEs and ADRs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rates (ORRs) | Up to 24 weeks | Objective response rates (ORRs). ORR is defined as the proportion of treated patients who achieve a best overall response (BOR) of partial response (PR) or complete response (CR) according to the response evaluation criteria in solid tumors (RECIST) version 1.1. |
| Prescription dose of Piqray in combination with fulvestrant | Up to 24 weeks | Prescription dose of Piqray in combination with fulvestrant |
Countries
South Korea
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed