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Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study

StatusRecruiting
PhasePhase 2
Started2022-10-01
View on ClinicalTrials.gov ↗

Amendment history

2026-07-17
Enrolling by Invitation→Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v2
Trial statusEnrolling by Invitation→Recruiting
Primary completion date2024-04-30→2027-04-30
Completion date2026-12-31→2028-12-31
Enrollment target94→64
Eligibility criteria+415 characters
Inclusion Criteria: WomenAccording ≥to 18the and ≤ 70 yearsdefinition of agethe withlatest treatment-naïveASCO/CAP breast cancer Histopathologically confirmedguidelines, early or locally advanced HER2- negative invasive breast cancer as definedconfirmed by thehistopathology ASCO/CAP guidelines while meetingmeets the following conditions: HER2 negative: IHC 0/1+or IHC2+with +no butamplification of ISH negative; Tumor stage: II-III; Primary tumor size: ≥ 11cm Lymph cmnode Nodal Statusstatus: N0-3 Inflammatory breast cancer patients with measurable lesions (according to RECIST 1.1 standard) Pati [...] [...]
Study sitesdetails revised at 1 of 1 site
Study title+58 characters
Neoadjuvant Fluzoparib Combined With Camrelizumab infor GermlineNeoadjuvant Treatment of Embryogenic BRCA-mutated Mutation HER2-negative Negative Breast Cancer: an Open, Single Arm, Multicenter Study
2022-11-14
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start dateestimated 2022-10-15→confirmed 2022-10-01
Study sites0→1
2022-10-10
Original filing
This study is an open-label, single-arm, multicenter clinical study. 64 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。
Trial Details
NCT Number NCT05576389
Lead Sponsor Peking University People's Hospital
Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Conditions Germline BRCA-mutated HER2-negative Breast Cancer
Enrollment 64 participants
Start Date 2022-10-01
Primary Completion 2027-04-30 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-21