A Post Marketing Surveillance on Piqray in Korea

Breast Cancer Clinical Trial

Official title:

A Post Marketing Surveillance on Piqray (Alpelisib) in Korea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05293470
• Other study ID #: CBYL719CKR01
• Status: Recruiting
• Start date: June 29, 2022
• Est. completion date: May 12, 2027

Study information

• Verified date: November 2023
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: May 12, 2027
• Est. primary completion date: May 12, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Cheonan Si	Chungcheongnam Do
Korea, Republic of	Novartis Investigative Site	Daejeon
Korea, Republic of	Novartis Investigative Site	Deogyang Gu Goyang Si	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Jeollanam
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Songpa-gu	Seoul
Korea, Republic of	Novartis Investigative Site	Suwon si	Gyeonggi Do

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AEs	Incidence of AEs, including SAEs and ADRs	24 weeks
Secondary	Objective response rates (ORRs)	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.	Up to 24 weeks
Secondary	Prescription dose of Piqray in combination with fulvestrant	Prescription dose of Piqray in combination with fulvestrant	Up to 24 weeks