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

September 15, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. HER2 positive recurrent or metastasis breast cancer.
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  3. Adequate organ function.
  4. Signed, written inform consent obtained prior to any study procedure.

Exclusion Criteria:

  1. Patients received more than 1 line of chemotherapy or immunotherapy in the phase of recurrence / metastasis.
  2. 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.
  3. Assessed by the investigator to be unable receive systemic chemotherapy.
  4. 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.
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel
Time Frame: Approximately 2 months
Peak Plasma Concentration (Cmax) of pyrotinib
Approximately 2 months
Pharmacokinetic parameter: AUC of pyrotinib and docetaxel
Time Frame: Approximately 2 months
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
Time Frame: Approximately 17 months
Objective Response Rate
Approximately 17 months
AEs+SAEs
Time Frame: Approximately 17 months
Adverse Events and Serious Adverse Events
Approximately 17 months
λz
Time Frame: Approximately 6 months
Approximately 6 months
The incidence of≥3 grade diarrhea with different treatment
Time Frame: Approximately 17 months
Approximately 17 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2020

Primary Completion (Actual)

August 10, 2022

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 26, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLTN-Ig

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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