Breast Cancer
Conditions
Brief summary
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.
Detailed description
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
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients eligible for and treated with the study drug according to the approved label in South Korea * Patients who provide signed and dated written informed consent, either personally or through a legally acceptable representative.
Exclusion criteria
* Participation in any interventional trial during the treatment of the study drug * Other off-label indications according to the approved label in South Korea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs) | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-world progression free survival (rwPFS) | 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 | 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. |
Countries
South Korea
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed