Clinical trial NCT05775549: A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Ovarian Cancer
Keywords: Real-world evidence
Homologous recombination deficiency
breast cancer gene
breast cancer gene mutated
breast cancer gene wild type
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-03-20
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed AOC BRCAwt with available HRD status who have been prescribed 1L olaparib maintenance treatment.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical and Demographics characteristics
timeFrame: At Index date - first olaparib prescription (Jan 2017 to Dec 2021)
Secondary outcomes:
measure: Real-world time to first subsequent treatment or death (rwTFST)
timeFrame: Jan 2017 to Jun 2023
measure: Real-world time to treatment discontinuation or death (rwTTD)
timeFrame: Jan 2017 to Jun 2023
measure: Number of patients with clinical event of interest (CEI)
timeFrame: Jan 2017 to Jun 2023
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Annapolis
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: New York
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
References: