A Post Marketing Surveillance on Piqray in Korea

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05293470

Collaborator

(none)

900

Enrollment

57.4

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Piqray

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

900 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Post Marketing Surveillance on Piqray (Alpelisib) in Korea

Anticipated Study Start Date :

Jul 31, 2022

Anticipated Primary Completion Date :

May 12, 2027

Anticipated Study Completion Date :

May 12, 2027

Arms and Interventions

Arm	Intervention/Treatment
Piqray Patients prescribed with Piqray	Other: Piqray There is no treatment allocation. Patients administered Piqray by prescription will be enrolled. Other Names: Alpelisib

Arm

Intervention/Treatment

Piqray

Patients prescribed with Piqray

Other: Piqray

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

Other Names:

Alpelisib

Outcome Measures

Primary Outcome Measures

Incidence of AEs [24 weeks]
Incidence of AEs, including SAEs and ADRs

Secondary Outcome Measures

Objective response rates (ORRs) [Up to 24 weeks]
Objective response rates (ORRs). ORR is defined as the proportion of treated patients who achieve a best overall response (BOR) of partial response (PR) or complete response (CR) according to the response evaluation criteria in solid tumors (RECIST) version 1.1.
Prescription dose of Piqray in combination with fulvestrant [Up to 24 weeks]
Prescription dose of Piqray in combination with fulvestrant

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.