A Post Marketing Surveillance on Piqray in Korea

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Piqray

Clinical Study ID

NCT05293470
CBYL719CKR01
  • Ages 18-100
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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, PIK3CAmutated, advanced or metastatic breast cancer.

  2. Patients who have progressed on prior endocrine based therapy and are going to startPiqray treatment for the first time in accordance with the locally approved label.

  3. Patients who are willing to provide written informed consent

Exclusion

Exclusion Criteria:

Subjects eligible for this study must not meet the following criteria:

  1. Patients with contraindication according to prescribing information for Piqray inKorea.
  • Severe hypersensitivity to Piqray or to any of its components

  1. Female subjects who are pregnant and nursing (lactating)

  2. Patients who are sexually active but not willing to follow contraceptive precautionsduring taking Piqray.

  3. Participants who receive or are going to receive any investigational medicine duringsurveillance period.

Study Design

Total Participants: 900
Treatment Group(s): 1
Primary Treatment: Piqray
Phase:
Study Start date:
June 29, 2022
Estimated Completion Date:
May 12, 2027

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Cheonan Si, Chungcheongnam Do 31116
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Deogyang Gu Goyang Si, Gyeonggi Do 10475
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Suwon si, Gyeonggi Do 16499
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Songpa-gu, Seoul 138-736
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Busan, 48108
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Daejeon, 302-241
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Jeollanam, 519763
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

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