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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04367090

Enrollment

Registered

2020-04-29

Start date

2020-05-28

Completion date

2023-05-24

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Brief 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.

Interventions

DRUGDocetaxel, trastuzumab

Docetaxel and trastuzumab once per cycle

DRUGPyrotinib

Pyrotinib 400/320 mg orally daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026