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Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer

NCT04367090 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2023-09-18

No results posted yet for this study

Summary

The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.

The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.

Conditions

Interventions

DRUG

Docetaxel, trastuzumab

Docetaxel and trastuzumab once per cycle

DRUG

Pyrotinib

Pyrotinib 400/320 mg orally daily

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2022-08-10
Completion
2023-05-24

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 NCT04367090 on ClinicalTrials.gov