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Recruiting Observational

A Post Marketing Surveillance on Piqray in Korea

NCT05293470 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2022-06-29
Last updated
2026-06-17

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Piqray

Piqray: There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • Incidence of AEs — 24 weeks
    Incidence of AEs, including SAEs and ADRs

Trial sites (19)

FacilityCityRegionStatus
Novartis Investigative Site Cheonan Si Chungcheongnam-do Recruiting
Novartis Investigative Site Daegu Dalseo gu Recruiting
Novartis Investigative Site Goyang-si Gyeonggi-do Recruiting
Novartis Investigative Site Suwon Gyeonggi-do Recruiting
Novartis Investigative Site Gyeonggi-do Korea Recruiting
Novartis Investigative Site Seoul Korea Recruiting
Novartis Investigative Site Seoul Seoul Completed
Novartis Investigative Site Seoul Seoul Recruiting
Novartis Investigative Site Seoul Yangcheon gu Recruiting
Novartis Investigative Site Busan South Korea Recruiting
Novartis Investigative Site Busan South Korea Recruiting
Novartis Investigative Site Daegu South Korea Recruiting
Novartis Investigative Site Daejeon South Korea Recruiting
Novartis Investigative Site Jeollanam South Korea Recruiting
Novartis Investigative Site Kyunggi South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05293470 on ClinicalTrials.gov ↗ ← All trials in South Korea