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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Metastatic Breast Cancer

Treatments: Drug: Pyrotinib; Drug: Docetaxel, trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04367090

BLTN-Ig

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

Pyrotinib and docetaxel plus trastuzumab

Experimental group

Treatment:

Drug: Docetaxel, trastuzumab

Drug: Pyrotinib