NCT05165225View on ClinicalTrials.gov

Phase II Neoadjuvant Pyrotinib Combined with Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

July 13, 2021

Primary Completion Date

September 30, 2023

Study Completion Date

March 31, 2028

Conditions
Breast CancerHER2-low-expressing Breast CancerHormone Receptor-positive Breast CancerNeoadjuvant Therapy
Interventions
DRUG

Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment

Drug: Pyrotinib pyrotinib 320mg orally daily Drug: Epirubicin epirubicin 90mg/m\^2 d1 iv Q3W for 4 cycles Drug: Cyclophosphamide cyclophosphamide 600mg/m\^2 d1 iv Q3W for 4 cycles Drug: Docetaxel docetaxel 100mg/m\^2 d1 iv Q3W for 4 cycles

Trial Locations (1)

510120

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou

All Listed Sponsors
collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER