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

PHASE1RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

November 1, 2026

Study Completion Date

November 1, 2028

Conditions
Breast Cancer
Interventions
DRUG

Pyrotinib low dose group

Pyrotinib: 320mg, peros(po),once a day(qd) ,every 3 weeks(q3w) 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 normal dose group

Pyrotinib: 400mg, peros(po),once a day(qd) ,every 3 weeks(q3w) 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

The First People's Hospital of Xuzhou

OTHER

collaborator

The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

OTHER

collaborator

The Second People's Hospital of Changshu

UNKNOWN

collaborator

Shuyang County Traditional Chinese Medicine Hospital

UNKNOWN

collaborator

Affiliated Hospital of Nantong University

OTHER

collaborator

Affiliated Hospital of Jiangsu University

OTHER

collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

lead

The First Affiliated Hospital with Nanjing Medical University

OTHER