Observational assessment of Piqray for breast cancer in Korea
A Post Marketing Surveillance on Piqray (Alpelisib) in Korea
This study is testing how safe and effective Piqray is for postmenopausal women and men with advanced breast cancer who have a specific genetic mutation and are starting this treatment for the first time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 17 sites (Cheonan Si, Chungcheongnam-do and 16 other locations) |
| Trial ID | NCT05293470 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of Piqray in patients with advanced or metastatic breast cancer in a real-world setting. It will involve postmenopausal women and men with hormone receptor-positive, HER2-negative, PIK3CA mutated breast cancer who are starting Piqray treatment for the first time. Participants will be monitored for up to 24 weeks, with follow-up for safety extending 30 days after treatment completion or early withdrawal. Data will be collected from multiple centers across Korea.
Who should consider this trial
Good fit: Ideal candidates include postmenopausal women and men with hormone receptor-positive, HER2-negative, PIK3CA mutated advanced or metastatic breast cancer who have progressed on prior endocrine therapy.
Not a fit: Patients who are pregnant, nursing, or have severe hypersensitivity to Piqray will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Piqray for patients with advanced breast cancer.
How similar studies have performed: Other studies have shown success with similar observational approaches in assessing cancer treatments, indicating potential for valuable findings in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cheonan Si, Chungcheongnam-do and 16 other locations
- Novartis Investigative Site — Cheonan Si, Chungcheongnam-do, South Korea (Recruiting)
- Novartis Investigative Site — Daegu, Dalseo gu, South Korea (Recruiting)
- Novartis Investigative Site — Deogyang Gu Goyang Si, Gyeonggi-do, South Korea (Recruiting)
- Novartis Investigative Site — Suwon, Gyeonggi-do, South Korea (Recruiting)
- Novartis Investigative Site — Gyeonggi-do, Korea, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
- Novartis Investigative Site — Daegu, South Korea (Recruiting)
- Novartis Investigative Site — Daejeon, South Korea (Recruiting)
- Novartis Investigative Site — Jeollanam, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Completed)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.