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

AstraZeneca

Status: Completed

Conditions: Advanced Ovarian Cancer

Treatments: Other: None (Observational Study)

Study type: Observational

Funder types: Industry

Identifiers

NCT05775549

D0818R00008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female adult, age ≥ 18 years
• BRCAwt AOC diagnosed with any approved BRCA test
• Has documented HRD status based on available test results
• Received 1L olaparib maintenance monotherapy following platinum chemotherapy
• Patients must have been treated with platinum-based chemotherapy at first-line

Exclusion criteria

• Received another poly adenosine diphosphate ribose polymerase (PARP) inhibitor or bevacizumab before or while prescribed olaparib
• Participation in an interventional clinical study

Trial design

24 participants in 1 patient group

Retrospective Cohort

Description:

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

Treatment:

Other: None (Observational Study)