MedTrace Logo

Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

NCT03756064 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-08-13

No results posted yet for this study

Summary

This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Conditions

Interventions

DRUG

Pyrotinib

Pyrotinib: 400mg orally daily

DRUG

Trastuzumab

Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles;

DRUG

Docetaxel

Docetaxel: 75mg/m2 for a total of 6 cycles

DRUG

Carboplatin

Carboplatin: AUC=5 for a total of 6 cycles

DRUG

Placebo Oral Tablet

Placebo Oral Tablet: 400mg orally daily

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Ding Xiaowen, DR. · Zhejiang Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-07-31
Completion
2021-07-31

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 NCT03756064 on ClinicalTrials.gov