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Olaparib

Patients with newly diagnosed AOC BRCAwt with known HRD status who have been prescribed 1L olaparib maintenance treatment.

None (Observational Study)

This study will collect the data from existing patient medical records at US cancer centers. The study will include patients with BRCAwt ovarian cancer who have been prescribed first line (1L) olaparib maintenance treatment.

This is a United States (US) based multicenter, retrospective, observational cohort study with data abstracted from patient medical records.

In this observational study, it is planned to include approximately 150 US female patients with newly diagnosed advanced ovarian cancer (AOC) who were tumor biomarker tested between first diagnosis with AOC and first prescription of 1L olaparib maintenance monotherapy as tumor breast cancer gene wild type (BRCAwt) with a known homologous recombination deficiency (HRD) status.

This retrospective cohort study will include patients with first olaparib prescription between Jan 2017 and Dec 2021. All data collection will be retrospective. Data will be collected from the date of first olaparib prescription (index date) with a follow-up period of at least 18 months post index date.

A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer

FLAME - First Line olAparib Maintenance bEyond BRCA An Observational Cohort Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy Beyond BRCA Mutant Status in Newly Diagnosed Advanced Ovarian Cancer

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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.

Clinical and Demographic characteristics including disease/FIGO stage, histology and tumor grade at initial Ovarian Cancer diagnosis, cancer antigen 125 (CA-125) level, Eastern Cooperative Oncology Group (ECOG) or other performance status, number and type of chemotherapy cycles, cytoreductive/debulking surgery type and outcomes, and selected comorbidities at index date will be described.

Summary statistics will be used to describe the Demographics and clinical characteristics.

The outcome will be measured for HRD+ patients.

rwTFST is defined as the time from the index date (date of the first olaparib prescription) to the earliest of the date of death or commencement of first subsequent anticancer treatment.

The outcome will be measured for HRD+ patients.

rwTTD is defined as the time from the index date to the earliest of the date of death or discontinuation of olaparib.

The outcome will be measured for HRD+ patients.

To summarize the real-world safety and tolerability profile based on pre-specified CEIs of 1L olaparib maintenance monotherapy in BRCAwt newly diagnosed AOC patients regardless of HRD status.

Merck Sharp & Dohme LLC

AstraZeneca

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer	NCT05775549	Advanced Ovaria...	None (Observati...	18 Years - 130 Years	AstraZeneca
A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer	NCT05775549	Advanced Ovaria...	None (Observati...	18 Years - 130 Years	AstraZeneca

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