MedTrace Logo

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

NCT06770296 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-01-13

No results posted yet for this study

Summary

Evaluate the safety and efficacy of Pyrotinib at different doses in combination with trastuzumab and paclitaxel chemotherapy for first-line treatment of HER2-positive advanced breast cancer.

Conditions

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)

Sponsors & Collaborators

  • The First People's Hospital of Xuzhou

    collaborator OTHER

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

    collaborator OTHER

  • The Second People's Hospital of Changshu

    collaborator UNKNOWN

  • Shuyang County Traditional Chinese Medicine Hospital

    collaborator UNKNOWN

  • Affiliated Hospital of Nantong University

    collaborator OTHER

  • Affiliated Hospital of Jiangsu University

    collaborator OTHER

  • The Affiliated Hospital of Xuzhou Medical University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Yongmei Yin, Ph.D · 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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-11-01
Completion
2028-11-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06770296 on ClinicalTrials.gov