Status:
COMPLETED
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2023
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04367090
Start Date
May 28 2020
End Date
May 24 2023
Last Update
September 18 2023
Active Locations (1)
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1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000