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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 28, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07380646). This is a study registration, not published results. Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 97 participants (ESTIMATED). Conditions: Leucogen, Ribociclib, Neutropenia (Low White Blood Cell Count), Breast Cancer. Interventions: DRUG: Treat Regimen. Primary outcome measures: incidence of severe neutropenia , From enrollment to the end of treatment at 16 weeks. Brief summary: This study is a multicenter, single-arm, open-label Phase II exploratory clinical trial designed to evaluate whether prophylactic use of leucogen can reduce the incidence of Grade 3 or higher neutropenia in early-stage HR+/HER2- breast cancer patients receiving ribociclib combined with endocrine therapy. The study plans to enroll 97 patients using a Simon two-stage design, with the primary endpoint being the incidence of severe neutropenia within 4 treatment cycles (4 months) after initiation. Secondary endpoints include the incidence of all-grade neutropenia, febrile neutropenia, ribociclib treatment intensity, and safety. The study will systematically assess the preventive efficacy and safety of leucogen to provide a basis for subsequent Phase III randomized controlled trials.