The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study

PHASE2RecruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

November 1, 2026

Study Completion Date

December 1, 2026

Conditions
Breast Cancer
Interventions
DRUG

Pyrotinib dose escalation

Pyrotinib: 240mg in the first week, 320mg in the second week, and 400mg in the third week and thereafter, by mouth(po),once a day(qd) Trastuzumab: 8mg/Kg in the first cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel: 75mg/m2,intravenous(iv), every 3 weeks(q3w)

DRUG

Pyrotinib dose normal

Pyrotinib: 400mg per week, by mouth(po),once a day(qd) Trastuzumab: 8mg/Kg in the first cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel: 75mg/m2,intravenous(iv), every 3 weeks(q3w)

Trial Locations (1)

Unknown

RECRUITING

Jiangsu Provincial People's Hospital, Nanjing

All Listed Sponsors
collaborator

Zhongda Hospital

OTHER

collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

collaborator

Jingjiang People's Hospital

OTHER

collaborator

Yancheng First People's Hospital

OTHER

collaborator

Affiliated Hospital of Jiangnan University

OTHER

collaborator

Affiliated Hospital of Nantong University

OTHER

collaborator

Anhui Provincial Cancer Hospital

OTHER

collaborator

Huai'an First People's Hospital

OTHER

collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

collaborator

Suzhou Municipal Hospital

OTHER

collaborator

Affiliated Hospital of Jiangsu University

OTHER

lead

The First Affiliated Hospital with Nanjing Medical University

OTHER

NCT06254690 - The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study | Biotech Hunter | Biotech Hunter