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Pyrotinib Combined With Trastuzumab, Dalpiciclib and Letrozole for HR+/HER2+ Breast Cancer
NCT05800756Phase 2
Key facts
- Status
- Unknown
- Start
- Aug 2022
- Primary completion
- May 2024
- Countries
- 1
- Sponsor
- Yantai Yuhuangding Hospital
- Modality
- Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
- Drugs
- pyrotinibdalpiciclib
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of pyrotinib and dalpiciclib in breast cancer, sponsored by Yantai Yuhuangding Hospital. Primary endpoint: Pathologic Complete Response up to 2 years. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
cohort 1
Patients with stage II-III HR+/HER2+ breast cancer receiving neoadjuvant therapy
03
Who it enrols
Women aged >= 18 years with newly treated stage II-III HR+/HER2+ breast cancer, ECOG PS 0-1, adequate organ function, and LVEF >= 55%.
04
Endpoints
Primary
Pathologic Complete Response
Secondary
Objective Response Rate
Breast-Conserving Surgery Rate
Safety Profile
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