A Post Marketing Surveillance on Piqray in Korea

A Post Marketing Surveillance on Piqray (Alpelisib) in Korea

ClinicalTrials.gov Identifier: NCT05293470

Novartis Reference Number: CBYL719CKR01

Last Update: Jan 18, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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

Condition

Breast Cancer

Phase

Not Given

Overall status

Recruiting

Start date

Jun 29, 2022

Completion date

May 12, 2027

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Other

Piqray

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

Eligibility Criteria

Inclusion Criteria:

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

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.