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

Metastatic Breast Cancer Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367090
• Other study ID #: BLTN-Ig
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2020
• Est. completion date: May 24, 2023

Study information

• Verified date: September 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: May 24, 2023
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Docetaxel, trastuzumab
Docetaxel and trastuzumab once per cycle
• Pyrotinib
Pyrotinib 400/320 mg orally daily

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel	Peak Plasma Concentration (Cmax) of pyrotinib	Approximately 2 months
Primary	Pharmacokinetic parameter: AUC of pyrotinib and docetaxel	Area under the plasma concentration versus time curve (AUC) of pyrotinib and docetaxel	Approximately 2 months
Secondary	ORR	Objective Response Rate	Approximately 17 months
Secondary	AEs+SAEs	Adverse Events and Serious Adverse Events	Approximately 17 months
Secondary	?z		Approximately 6 months
Secondary	The incidence of=3 grade diarrhea with different treatment		Approximately 17 months