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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Piqray | Patients prescribed with Piqray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piqray | Other | There is no treatment allocation. Patients administered Piqray by prescription will be enrolled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs | Incidence of AEs, including SAEs and ADRs | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rates (ORRs) | 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. | Up to 24 weeks |
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Inclusion Criteria:
Subjects eligible for this study must meet all of the following criteria:
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.
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Patients who are going to receive Piqray per locally approved label are eligible and will be prescribed with Piqray under routine medical practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Cheonan Si | Chungcheongnam-do | 31116 | South Korea | |
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| Prescription dose of Piqray in combination with fulvestrant |
Prescription dose of Piqray in combination with fulvestrant |
| Up to 24 weeks |
| Novartis Investigative Site |
| Recruiting |
| Daegu |
| Dalseo gu |
| 42602 |
| South Korea |
| Novartis Investigative Site | Recruiting | Goyang-si | Gyeonggi-do | 10475 | South Korea |
| Novartis Investigative Site | Recruiting | Suwon | Gyeonggi-do | 16499 | South Korea |
| Novartis Investigative Site | Recruiting | Gyeonggi-do | Korea | 11765 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Korea | 02841 | South Korea |
| Novartis Investigative Site | Completed | Seoul | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 150-713 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Yangcheon gu | 07985 | South Korea |
| Novartis Investigative Site | Recruiting | Busan | 48108 | South Korea |
| Novartis Investigative Site | Recruiting | Busan | 602-030 | South Korea |
| Novartis Investigative Site | Recruiting | Daegu | 705 718 | South Korea |
| Novartis Investigative Site | Recruiting | Daejeon | 302-241 | South Korea |
| Novartis Investigative Site | Recruiting | Jeollanam | 519763 | South Korea |
| Novartis Investigative Site | Recruiting | Kyunggi | 425-020 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 04763 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 06273 | South Korea |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C585539 | Alpelisib |
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