Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant )
NCT04033172 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2019-07-25
Summary
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, single-center clinical study of pyrotinib plus fulvestrant as the therapy HR+/HER2+ metastatic breast cancer.
Conditions
Interventions
- DRUG
-
Pyrotinib Plus Fulvestrant
Pyrotinib: 400 mg/d, q.d., p.o. A course of treatment need 28 days. Fulvestrant: 500 mg/m2 q.d. i.m. A course of treatment need 28 day. First course needs extra dose of fulvestrant 500 mg/m2 q.d. i.m. on day 15.
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences
lead OTHER
Principal Investigators
-
Peng Yuan · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
-
Jian Yue · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-01
- Primary Completion
- 2021-03-01
- Completion
- 2021-09-01
Countries
- China
Study Locations
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