Breast cancer
Conditions
Interventions
None listed
Sponsors
SHOWA University Advanced Cancer Treatment Laboratory
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects of the primary research Patients with metastatic breast cancer treated with Abemaciclib during the period from November 1 2018 to December 31 2019 Subjects of the secondary research The Cases are determined as those reported as having Abemaciclib-induced ILD in the primary research including suspected cases and matched cases without Abemaciclib-induced ILD are selected as Controls. Subjects of the nested case control study Case presented with Abemaciclib-induced ILD: Among the cases accumulated for the primary research, those determined to have Abemaciclib-induced ILD by the Central Evaluation Committee. Evaluation criteria used in the Central Evaluation Committee are set forth separately. Control presented with no Abemaciclib-induced ILD Among the cases accumulated for the primary research, those who did not develop Abemaciclib-induced ILD and whose clinicopathological background is matched to that of cases developed Abemaciclib-induced ILD i.e Case. Cases of subjects whose existing information is approved by the subjects themselves or their proxies to be used for research purpose. Cases in which subjects received an explanation of the study contents and if obtaining informed consent from these subjects is difficult those in which subjects do not refuse the use of their clinical information. Obtaining informed consent from the subjects themselves can be omitted.
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of Abemaciclib-induced ILD Risk factors associated with Abemaciclib-induced ILD | — |
Countries
Japan
Contacts
Public ContactOffice CSPOR-BC
CSPOR-BC Office
Outcome results
None listed