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Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer

NCT03847818 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2019-03-01

No results posted yet for this study

Summary

This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Conditions

Interventions

DRUG

Pyrotinib+Trastuzumab+Docetaxel+Carboplatin

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 or 6 for a total of 6 cycles

Sponsors & Collaborators

  • Shandong University

    lead OTHER

Principal Investigators

  • Yu Zhigang, DR. · The Second Hospital of Shandong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-03-01
Completion
2021-02-28

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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 NCT03847818 on ClinicalTrials.gov