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Completed

NCT Number: NCT04367090

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Docetaxel, trastuzumab

Drug

Docetaxel and trastuzumab once per cycle

Pyrotinib

Drug

Pyrotinib 400/320 mg orally daily

Primary outcomes

  1. Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel

    Time frame: Approximately 2 months

    Peak Plasma Concentration (Cmax) of pyrotinib

  2. 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

Secondary outcomes

  1. ORR

    Time frame: Approximately 17 months

    Objective Response Rate

  2. AEs+SAEs

    Time frame: Approximately 17 months

    Adverse Events and Serious Adverse Events

  3. λz

    Time frame: Approximately 6 months

  4. The incidence of≥3 grade diarrhea with different treatment

    Time frame: Approximately 17 months

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 29, 2020
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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