protocolSection identificationModule nctId: NCT06377267, orgStudyIdInfo id: ESR-20-21103, briefTitle: Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial), acronym: STROBE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Vall d'Hebron Institute of Oncology, class: OTHER, descriptionModule briefSummary: Background:The study aims to address the challenge of accurately identifying patients with ovarian cancer who would benefit from poly-ADP ribose inhibitors (PARPi) as first-line maintenance therapy. While BRCA1/2-mutated epithelial ovarian cancer (EOC) patients have shown significant benefits from PARPi treatment, the efficacy in homologous recombination deficient (HRD) patients remains inconclusive. Current assays used to estimate HR status do not effectively differentiate between patients who benefit most from PARPi and those who do not, making it inefficient to treat all patients. There is a need for a more accurate HR status testing method to optimize PARPi benefit. This study aims to assess the performance of the VHIO-CARD-300 test in determining HR status compared to SOPHiA DDM™ Dx HRD Solution.Summary:The study is a prospective, non-randomized trial designed to evaluate the concordance of the VHIO-CARD-300 test in establishing HR status compared to SOPHiA DDM™ Dx HRD Solution. Additionally, it aims to assess the association between HRD status determined by the VHIO-CARD-300 test and treatment efficacy. Patients with advanced FIGO stage III-IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer will be invited to participate. Those eligible will undergo testing with both VHIO-CARD-300 and SOPHiA DDM™ Dx HRD Solution. Patients classified as HRD positive will receive olaparib in combination with bevacizumab, while others will receive bevacizumab alone. Treatment will be administered according to approved doses, with follow-up evaluations conducted until RECIST progression., conditionsModule conditions: Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Bevacizumab, interventions name: Olaparib, outcomesModule primaryOutcomes measure: Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution, secondaryOutcomes measure: Performance Assessment of VHIO-CARD-300 Test for HR Status Identification, secondaryOutcomes measure: Association Between VHIO-CARD-300 Test Groups and Efficacy Outcomes(i.e., HRD positive and HRD negative) and efficacy outcomes., secondaryOutcomes measure: Analysis of Progression-Free Survival (PFS) and Overall Survival (OS) in Discrepant HRD Cases, secondaryOutcomes measure: Safety and Tolerability of Olaparib Plus Bevacizumab, secondaryOutcomes measure: To evaluate the failure rate for the VHIOCARD-300 test and SOPHiA DD Dx HRD Solution., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vall d'Hebron Institute of Oncology, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Ana Oaknin, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False