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

Study Overview
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Brief Summary
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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.

Official Title
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An Open, Single-arm and Multi-center Pharmacokinetic Study of Pyrotinib and Docetaxel Plus Trastuzumab in Patients With HER2 Positive Recurrent or Metastasis Breast Cancer.

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Docetaxel, trastuzumab
* Drug: Pyrotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HER2 positive recurrent or metastasis breast cancer. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Adequate organ function. Signed, written inform consent obtained prior to any study procedure. Exclusion Criteria: Patients received more than 1 line of chemotherapy or immunotherapy in the phase of recurrence / metastasis. History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab ,or Pertuzumab used in the neo-adjuvant or adjuvant setting. Assessed by the investigator to be unable receive systemic chemotherapy. History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pyrotinib and docetaxel plus trastuzumab<br> | Drug: Docetaxel, trastuzumab<br>* Docetaxel and trastuzumab once per cycle<br>Drug: Pyrotinib<br>* Pyrotinib 400/320 mg orally daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel | Peak Plasma Concentration (Cmax) of pyrotinib | Approximately 2 months | 
| Pharmacokinetic parameter: AUC of pyrotinib and docetaxel | Area under the plasma concentration versus time curve (AUC) of pyrotinib and docetaxel | Approximately 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response Rate | Approximately 17 months | 
| AEs+SAEs | Adverse Events and Serious Adverse Events | Approximately 17 months | 
| λz |  | Approximately 6 months | 
| The incidence of≥3 grade diarrhea with different treatment |  | Approximately 17 months |