A Post Marketing Surveillance on Piqray in Korea

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: Piqray

• Registration Number: NCT05293470
• Lead Sponsor: Novartis Pharmaceuticals

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Study Start: 2022-06-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-03
• Primary Completion: 2027-05-12
• Study Completion: 2027-05-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Piqray	Piqray	Patients prescribed with Piqray

Primary Outcome Measures

Name	Time	Method
Incidence of AEs	24 weeks	Incidence of AEs, including SAEs and ADRs

Secondary Outcome Measures

Name	Time	Method
Prescription dose of Piqray in combination with fulvestrant	Up to 24 weeks	Prescription dose of Piqray in combination with fulvestrant
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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Seoul, Korea, Republic of