The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed (PSR) ovarian cancer in German hospitals and outpatient practices treated with olaparib.
Study Type
OBSERVATIONAL
Enrollment
276
To assess clinical effectiveness of olaparib maintenance monotherapy by assessment of progression free survival (PFS) in patients with BRCAm+ ovarian cancer. Methods and time intervals for tumor assessment depend on the investigator's decision.
Time frame: Date of first documented dose of olaparib to the date of progression (as judged by the investigator) or death (of any cause) whichever occurred before, assessed approximately up to 84 months
To collect and explore real-life data on patient outcomes in terms of Overall Survival (OS)
Time frame: Date of first documented dose of olaparib to death of any cause, assessed approximately up to 84 months
Time to first subsequent therapy (TFST)
Time frame: Date of first documented dose of olaparib to date of first administration of first subsequent therapy or death if this occurs before commencement of first subsequent treatment, assessed approximately up to 84 months
Progression-free survival 2 (PFS2)
Time frame: Date of first administration of first subsequent therapy to date of progression as assessed by the investigator or death, assessed approximately up to 84 months
Time to second subsequent therapy (TSST)
Time frame: Date of first documented dose of olaparib to date of first administration of second subsequent therapy or death if this occurs before commencement of second subsequent treatment, assessed approximately up to 84 months
Time to discontinuation of olaparib monotherapy (TDO)
Time frame: Date of first documented dose of olaparib montherapy to date of last documented dose of olaparib monotherapy or death whichever occurred before, assessed approximately up to 84 months
Assessment of health-related quality of life (HRQoL) in patients participating in the study.
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Research Site
Amberg, Germany
Research Site
Aschaffenburg, Germany
Research Site
Augsburg, Germany
Research Site
Bad Homburg, Germany
Research Site
Berlin, Germany
Research Site
Bonn, Germany
Research Site
Bottrop, Germany
Research Site
Brandenburg an der Havel, Germany
Research Site
Braunschweig, Germany
Research Site
Bremen, Germany
...and 58 more locations
Health related quality of life (HRQoL): Assessment of general cancer-associated and specific ovarian cancer associated parameters by use of standardized HRQoL questionnaires: * Functional assessment of Cancer Therapy for Patients with Ovarian Cancer (FACT-O) * Functional Assessment of Chronic Illness - Fatigue (FACIT-Fatigue) * Functional Living Index - Emesis (FLIE)
Time frame: Date of first visit to last visit. HRQoL are collected every 3 months up to 84 months
Safety of Olaparib: collection of Adverse Events (AE)
Type and frequeny of adverse event (AE), intensity, causal relationship to olaparib, outcome, seriousness, management of adverse event
Time frame: Date of first documented dose of Olaparib to last visit, assessed approximately up to 84 months