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A Post Marketing Surveillance on Piqray in Korea

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Breast Cancer

Interventions: Piqray

Countries: South Korea

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (19)

Cheonan Si, Chungcheongnam-do, South Korea
Daegu, Dalseo gu, South Korea
Goyang-si, Gyeonggi-do, South Korea
Suwon, Gyeonggi-do, South Korea
Gyeonggi-do, Korea, South Korea
Seoul, Korea, South Korea
Seoul, Seoul, South Korea
Seoul, Seoul, South Korea
Seoul, Yangcheon gu, South Korea
Busan, South Korea
Busan, South Korea
Daegu, South Korea
Daejeon, South Korea
Jeollanam, South Korea
Kyunggi, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea