Phase 2Not yet recruiting
Trastuzumab/Pertuzumab With Fulvestrant and Kurmoxilil in HR+/HER2+ Early Breast Cancer
Neoadjuvant Trastuzumab Plus Pertuzumab Combined With Fulvestrant and Kurmoxilil in HR+/HER2+ Early-Stage Breast Cancer: A Single-Arm Phase II Study
- Sponsor
- Hebei Medical University Fourth Hospital (Academic or other)
- Enrolment
- 31 planned
- Conditions
- Breast Cancer
- Interventions
- Trastuzumab (or biosimilar); Pertuzumab; Kurmoxilil; Fulvestrant
- Ages
- adults, older adults
- Registry
- NCT07857226
Full record on ClinicalTrials.gov
From the registry
This phase II single-arm study is designed to evaluate the neoadjuvant efficacy of a chemotherapy-free regimen consisting of trastuzumab, pertuzumab, kurmoxilil, 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.
Primary outcomes
- Investigator-Assessed tpCR
History
Study completion expected
Primary completion expected
Registered
Started