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

Summary

Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to normal-dose regimen for HER2-positive advanced first-line breast cancer

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)

Sponsors & Collaborators

• Zhongda Hospital

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Jingjiang People's Hospital

  collaborator OTHER

• Yancheng First People's Hospital

  collaborator OTHER

• Affiliated Hospital of Jiangnan University

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• Anhui Provincial Cancer Hospital

  collaborator OTHER

• Huai'an First People's Hospital

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Suzhou Municipal Hospital

  collaborator OTHER

• Affiliated Hospital of Jiangsu University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Principal Investigators

• Yongmei Yin · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2026-11-01

Completion

2026-12-01

Countries

• China

Study Locations