Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To fulfil the post-approval commitment of MFDS to conduct post-marketing surveillance, this study is designed to assess the known safety profile, identify previously unsuspected adverse reactions and to evaluate the effectiveness of Capivasertib under conditions of routine daily medical practice in Korea.
The objectives of this study are to assess the safety and effectiveness of Capivasertib (hereinafter "the study drug") in a real-world practice setting for patients prescribed with the study drug under the approved local label in South Korea.
Primary Objective To assess the safety of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea
Secondary Objective To assess effectiveness of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs) | The safety assessment should include all undesirable changes in medical findings (including clinical test findings) noted during medical visits as required by local practice guidelines, as well as all AEs associated with the study drug administration. | For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die. 30 days addtional follow up in case of not completing 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Real-world progression free survival (rwPFS) | Real-world progression free survival (rwPFS) for patients will be evaluated by routine clinical practice of the investigators. rwPFS will be defined as the time from first dose of the study drug until the date of disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from therapy or receives another anti-cancer therapy prior to progression.Subjects who have not progressed or died at the time of analysis will be censored at the date of their last follow-up assessment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients currently treated with or initiating the study drug under approved local label and conditions of routine daily medical practice in South Korea will be included in the study. This study will be conducted using a total surveillance method to investigate the safety and effectiveness of all patients being treated with the study drug.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Not yet recruiting | Busan | 34084 | South Korea | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Not provided
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die |
| Not yet recruiting |
| Busan |
| 49241 |
| South Korea |
| Research Site | Recruiting | Busan | 49267 | South Korea |
| Research Site | Not yet recruiting | Daejeon | 34943 | South Korea |
| Research Site | Recruiting | Daejeon | 35015 | South Korea |
| Research Site | Recruiting | Goyang-si | 10380 | South Korea |
| Research Site | Recruiting | Goyang-si | 10408 | South Korea |
| Research Site | Recruiting | Guri-si | 11923 | South Korea |
| Research Site | Recruiting | Incheon | 21565 | South Korea |
| Research Site | Recruiting | Incheon | 22332 | South Korea |
| Research Site | Not yet recruiting | Seongnam-si | 13620 | South Korea |
| Research Site | Recruiting | Seoul | 02841 | South Korea |
| Research Site | Recruiting | Seoul | 03722 | South Korea |
| Research Site | Not yet recruiting | Seoul | 06273 | South Korea |
| Research Site | Recruiting | Seoul | 06591 | South Korea |
| Research Site | Recruiting | Suwon | 16499 | South Korea |
| Research Site | Recruiting | Uijeongbu-si | 11765 | South Korea |
| D017437 |
| Skin and Connective Tissue Diseases |