Breast CancerNCT05293470
A Post Marketing Surveillance on Piqray in Korea
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 19 sites in South Korea.
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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Piqray
- How many people
- 900 participants
- Where
- 19 sitesSouth Korea
- Study dates
- 29 Jun 2022to 12 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are going to receive Piqray per locally approved label are eligible and will be prescribed with Piqray under routine medical practice.
Who may be able to join
- Subjects eligible for this study must meet all of the following criteria:
- 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.
- 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.
- Patients who are willing to provide written informed consent
Who cannot join
- Subjects eligible for this study must not meet the following criteria:
- Patients with contraindication according to prescribing information for Piqray in Korea.
- Severe hypersensitivity to Piqray or to any of its components
- Female subjects who are pregnant and nursing (lactating)
- Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray.
- Participants who receive or are going to receive any investigational medicine during surveillance period.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
19 sites in 1 country
South Korea19 sites, 18 recruiting
- Recruiting
Novartis Investigative Site
Busan, 48108
- Recruiting
Novartis Investigative Site
Busan, 602-030
- Recruiting
Novartis Investigative Site
Cheonan Si, Chungcheongnam-do, 31116
- Recruiting
Novartis Investigative Site
Daegu, Dalseo gu, 42602
- Recruiting
Novartis Investigative Site
Daegu, 705 718
- Recruiting
Novartis Investigative Site
Daejeon, 302-241
- Recruiting
Novartis Investigative Site
Goyang-si, Gyeonggi-do, 10475
- Recruiting
Novartis Investigative Site
Gyeonggi-do, Korea, 11765
- Recruiting
Novartis Investigative Site
Jeollanam, 519763
- Recruiting
Novartis Investigative Site
Kyunggi, 425-020
- Recruiting
Novartis Investigative Site
Seoul, Korea, 02841
- Completed
Novartis Investigative Site
Seoul, Seoul, 06351
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 150-713
- Recruiting
Novartis Investigative Site
Seoul, Yangcheon gu, 07985
- Recruiting
Novartis Investigative Site
Seoul, 03722
- Recruiting
Novartis Investigative Site
Seoul, 04763
- Recruiting
Novartis Investigative Site
Seoul, 05505
- Recruiting
Novartis Investigative Site
Seoul, 06273
- Recruiting
Novartis Investigative Site
Suwon, Gyeonggi-do, 16499
About this study
Official title: A Post Marketing Surveillance on Piqray (Alpelisib) in Korea
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
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Piqray
- Keywords
- Breast cancer, NIS, Piqray, Korea, Alpelisib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiqrayOther
Also called Alpelisib
There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Piqray | Patients prescribed with Piqray Receives: Other: Piqray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs
Incidence of AEs, including SAEs and ADRs
Measured: 24 weeks
Secondary outcomes (2)
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.
Measured: Up to 24 weeks
Prescription dose of Piqray in combination with fulvestrant
Prescription dose of Piqray in combination with fulvestrant
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start29 Jun 2022
- Primary completion12 May 2027 (estimated)
- Study completion12 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293470
- Sponsor's protocol ID
- CBYL719CKR01
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance on Piqray (Alpelisib) in Korea
- ClinicalTrials.gov ID
- NCT05293470
- Acronym / sponsor ID
- CBYL719CKR01
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, NIS, Piqray, Korea, Alpelisib
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 12 May 2027 (estimated)
- Study completion
- 12 May 2027 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Piqray | – | Other: PiqrayPatients prescribed with Piqray |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are going to receive Piqray per locally approved label are eligible and will be prescribed with Piqray under routine medical practice.
Key inclusion criteria (4 listed)
- 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.
- 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.
- Patients who are willing to provide written informed consent
Key exclusion criteria (6 listed)
- Patients with contraindication according to prescribing information for Piqray in Korea.
- Female subjects who are pregnant and nursing (lactating)
- Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray.
- Participants who receive or are going to receive any investigational medicine during surveillance period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiqrayAlso: AlpelisibThere is no treatment allocation. Patients administered Piqray by prescription will be enrolled. | Other | Piqray |
Primary outcome
Incidence of AEs
Time frame: 24 weeks
Incidence of AEs, including SAEs and ADRs
2 secondary outcomes
Objective response rates (ORRs)
Time frame: Up to 24 weeks
Prescription dose of Piqray in combination with fulvestrant
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 19 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.