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

Phase 1

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Docetaxel, trastuzumab; Drug: Pyrotinib

• Registration Number: NCT04367090
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-26
• Study First Posted: 2020-04-29
• Study Start: 2020-05-28
• Primary Completion: 2022-08-10
• Study Completion: 2023-05-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 97

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pyrotinib and docetaxel plus trastuzumab	Docetaxel, trastuzumab	-
Pyrotinib and docetaxel plus trastuzumab	Pyrotinib	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China