Study Description
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.
Interventions
Piqray
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.
Worldwide Contacts
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