Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario

Official title

Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario: A Retrospective and Prospective, Multicenter, Two Cohorts Study

Overview

This is a retrospective and prospective, multicenter, observational, two-cohorts study aimed to evaluate clinical outcomes and safety of patients diagnosed with advanced high grade ovarian cancer whose tumor was tested for the homologous recombination (HR) status using a validated HR deficiency test between January 2021 and January 2026. * Cohort A: Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy. * Cohort B: Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice.

Detailed description

This is a retrospective and prospective, multicenter, observational, two-cohorts study aimed to evaluate clinical outcomes and safety of patients diagnosed with advanced high grade ovarian cancer whose tumor was tested for the homologous recombination status using a validated HRD test between January 2021 and January 2026:

Cohort A: Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy.

Cohort B: Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice. Alive patients who have finished the first line treatment (including maintenance) with or without disease progression while signing the informed consent form will be enrolled retrospectively. Alive patients candidate to receive a first line therapy will be enrolledprospectively as soon as molecular data (BRCA status and HRD) are available.

Primary outcome measures

• Evaluate the clinical outcomes [Time frame: Until 3 years from enrollment]
• Evaluate the clinical outcomes [Time frame: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Time frame: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Time frame: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Time frame: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Time frame: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Time frame: Until 3 years from enrollment]
• Evaluate the safety in patients treated with targeted anticancer therapies in each study cohort [Time frame: Until 3 years from enrollment]

Secondary outcome measures (5)

• Describe the clinical outcomes [Time frame: Until 3 years from enrollment]
• Describe the clinical outcomes [Time frame: Until 3 years from enrollment]
• Describe the clinical outcomes [Time frame: Until 3 years from enrollment]
• Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A) [Time frame: Until 3 years from enrollment]
• Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B) [Time frame: Until 3 years from enrollment]

Eligibility criteria

Inclusion criteria

• Female, age ≥ 18 years at the time of diagnosis
• Patients diagnosed with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer undergone to Homologous Recombination test with the MyChoice HRD assay, FoundationOne DX assay or another validated HRD test, between January 2021 and January 2026:

• Patients with HRD score > 42 or Loss of Heterozygosity (LOH) score high or defined as HR deficient with other tests and treated with Bevacizumab and Olaparib after first line platinumbased chemotherapy will be retrospectively or prospectively enrolled in Cohort A
• Patients with HRD score < 42 or Loss of Heterozygosity (LOH) score low or defined as HR proficient with other tests and treated with first line platinum-based chemotherapy with or without bevacizumab or others targeted agents will be retrospectively or prospectively enrolled in Cohort B
• Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent.

Exclusion criteria

• Patients who have not performed a validated Homologous Recombination test on tumor sample.
• Patients with germline or somatic BRCA 1 or 2 mutations
• Patients death at the time of inclusion in the current study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 21 centers

• Istituto Tumori "Giovanni Paolo II" I.R.C.C.S. — Bari
• Azienda Ospedaliero Universitaria di Bologna - Policlinico S.Orsola-Malpighi — Bologna
• Azienda Ospedaliera S.Croce e Carle Cuneo — Cuneo
• Azienda Ospedaliera per l'emergenza Cannizzaro — Catania
• IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola
• Azienda Ospedaliero Universitario Careggi — Florence
• IRCCS Policlinico San Martino — Genova
• Fondazione IRCCS San Gerardo dei Tintori (Monza) — Monza
• … and 13 more centers

Identifiers

NCT: NCT06836219 · BeLIVE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗