A Post Marketing Surveillance on Piqray in Korea
1 other identifier
observational
900
1 country
17
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 24, 2022
CompletedStudy Start
First participant enrolled
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 12, 2027
July 9, 2025
July 1, 2025
4.9 years
March 15, 2022
July 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of AEs
Incidence of AEs, including SAEs and ADRs
24 weeks
Secondary Outcomes (2)
Objective response rates (ORRs)
Up to 24 weeks
Prescription dose of Piqray in combination with fulvestrant
Up to 24 weeks
Study Arms (1)
Piqray
Patients prescribed with Piqray
Interventions
There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.
Eligibility Criteria
Patients who are going to receive Piqray per locally approved label are eligible and will be prescribed with Piqray under routine medical practice.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Novartis Investigative Site
Cheonan Si, Chungcheongnam-do, 31116, South Korea
Novartis Investigative Site
Daegu, Dalseo gu, 42602, South Korea
Novartis Investigative Site
Deogyang Gu Goyang Si, Gyeonggi-do, 10475, South Korea
Novartis Investigative Site
Suwon, Gyeonggi-do, 16499, South Korea
Novartis Investigative Site
Gyeonggi-do, Korea, 11765, South Korea
Novartis Investigative Site
Busan, 48108, South Korea
Novartis Investigative Site
Busan, 602-030, South Korea
Novartis Investigative Site
Daegu, 705 718, South Korea
Novartis Investigative Site
Daejeon, 302-241, South Korea
Novartis Investigative Site
Jeollanam, 519763, South Korea
Novartis Investigative Site
Seoul, 02841, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Seoul, 04763, South Korea
Novartis Investigative Site
Seoul, 05505, South Korea
Novartis Investigative Site
Seoul, 06273, South Korea
Novartis Investigative Site
Seoul, 06351, South Korea
Novartis Investigative Site
Seoul, 158-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
March 24, 2022
Study Start
June 29, 2022
Primary Completion (Estimated)
May 12, 2027
Study Completion (Estimated)
May 12, 2027
Last Updated
July 9, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share