Status:
UNKNOWN
Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant )
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Breast Cancer
HER2-positive Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed).
- ECOG score ≤ 2, expected survival ≥ 3 months.
- Histology or cytology confirmed as breast cancer.
- Prior to trastuzumab and endocrine therapy and progression/recurrence.
- At least one RECIST 1.1 defined measurable lesions.
- Normal function of major organs.
Exclusion
- pregnant or lactating women
- Patients who have relapsed or progressed within 12 months of end of adjuvant or neoadjuvant therapy, including chemotherapy, target therapy (eg lapatinib， trastuzumab), or other anti-tumor therapy. Except for endocrine therapy.
- Severe chronic gastrointestinal diseases with diarrhea as the main symptom (such as Crohn's disease, malabsorption, or ≥2 grade diarrhea caused by any cause at baseline).
- Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.)
- Patients with central nervous system disorders or mental disorders
- Bone metastasis lesions only, no other measurable lesions.
- Hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg) without ideal control.
- Uncontrolled heart disease.
- Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome.
- Uncontrolled rain metastasis.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04033172
Start Date
November 1 2018
End Date
September 1 2021
Last Update
July 25 2019
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021