A Post Marketing Surveillance on Piqray in Korea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-29

Study Completion Date

2027-05-12

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Piqray

Patients prescribed with Piqray

Piqray

Intervention Type OTHER

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

Interventions

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Piqray

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

Intervention Type OTHER

Other Intervention Names

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Alpelisib

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No