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Recruiting Phase 2 NCT05582499

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

Trial Parameters

Condition Breast Neoplasm
Sponsor Fudan University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 716
Sex FEMALE
Min Age 18 Years
Max Age 70 Years
Start Date 2022-11-01
Completion 2026-12-31
Interventions
DalpiciclibPyrotinibSHR-A1811

Brief Summary

The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.

Eligibility Criteria

Inclusion Criteria: * Histologically confirmed invasive cancer of the breast and meet the clinical stage II(T2N0-1M0/T3N0M0)or III(T2N2M0/T3N1-2M0) criteria; * Age between18-70 years; * Eastern Cooperative Oncology Group (ECOG) performance status 0-1; * ER, PR and HER2 status were measured by immunohistochemistry (IHC); * LVEF≥55%; * Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\&E slices; * Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping; * At least one measurable lesion according to RECIST version 1.1 * Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous c

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