NCT04872985View on ClinicalTrials.gov

Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

April 20, 2021

Primary Completion Date

February 27, 2026

Study Completion Date

December 31, 2028

Conditions
Breast CancerHormone-receptor Positive Breast Cancer
Interventions
DRUG

Pyrotinib

400 mg orally once per day. Pyrotinib starts with a dose of 240 mg once daily for one week, followed by 320 mg once daily for the next week, before transitioning to 400 mg once daily as maintenance therapy.

DRUG

Epirubicin

100 mg/m2,q3W\*4

DRUG

Doxorubicin Hydrochloride Liposome Injection

30mg/m2, q3w\*4

DRUG

Cyclophosphamide

600 mg/m2, q3w\*4

DRUG

Docetaxel

100 mg/m2, q3w\*4

DRUG

Nab paclitaxel

120mg/m2 qw\*12 or 260mg/m2 q3w\*4

DRUG

Placebo

400 mg orally once per day

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