Breast Cancer, HER2-positive Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer, Pyrotinib, Fulvestrant
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 therapy HR+/HER2+ metastatic breast cancer.
Interventions
DRUGPyrotinib 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
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed). 2. ECOG score ≤ 2, expected survival ≥ 3 months. 3. Histology or cytology confirmed as breast cancer. 4. Prior to trastuzumab and endocrine therapy and progression/recurrence. 5. At least one RECIST 1.1 defined measurable lesions. 6. Normal function of major organs.
Exclusion criteria
1. pregnant or lactating women 2. 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. 3. 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). 4. Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.) 5. Patients with central nervous system disorders or mental disorders 6. Bone metastasis lesions only, no other measurable lesions. 7. Hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg) without ideal control. 8. Uncontrolled heart disease. 9. Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome. 10. Uncontrolled rain metastasis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Estimated up to 1 year | Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS (overall survival) | Estimated up to 1 year | Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death. |
| Objective Response Rate (ORR) | Estimated up to 1 year | Defined as proportion of complete response and partial response according to RECIST 1.1 criteria. |
Countries
China
Contacts
Primary ContactPeng Yuan
Backup ContactJian Yue
Outcome results
None listed