Trastuzumab/Pertuzumab With Fulvestrant and Culmerciclib in HR+/HER2+ Early Breast Cancer

StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

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  1. Interventions modified
    • Study title revised
    • Study description shortened, about 1 word
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II single-arm study is designed to evaluate the neoadjuvant efficacy of a chemotherapy-free regimen consisting of trastuzumab, pertuzumab, Culmerciclib, and fulvestrant in patients with treatment-naïve stage II-III hormone receptor-positive, HER2-positive breast cancer. The pathological complete response (pCR) rate serves as the primary endpoint. The study aims to assess whether the pCR rate meets or exceeds that achieved with standard chemotherapy plus dual HER2-targeted therapy, and to generate preliminary evidence to support the design of a future phase III randomized controlled trial.
Trial Details
NCT Number NCT07857226
Lead Sponsor Hebei Medical University Fourth Hospital
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov