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Pyrotinib as Neoadjuvant Agent for Non-objective Response HER2-positive Early Breast Cancer

NCT04717531 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-06-04

No results posted yet for this study

Summary

The study assesses the efficacy of neoadjuvant treatment with pyrotinib and trastuzumab with chemotherapy, mainly pathological complete response (pCR) rates in the breast and axilla.

And also assesses side effects, event-free survival (EFS), disease-free survival (DFS), distant disease-free survival (DDFS), and objective response rates (ORR).

Conditions

Interventions

DRUG

Pyrotinib

400mg, qd, po, day 1-21

DRUG

Trastuzumab

6 mg/kg, day 1

DRUG

Pertuzumab

420 mg, day 1

DRUG

Docetaxel

100 mg/m2, day 1

DRUG

Epirubicin

90mg/m2, day 1

DRUG

Cyclophosphamide

600 mg/m2, day 1

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Xiaoming Zha, MD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2023-06-01
Completion
2024-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT04717531 on ClinicalTrials.gov