breast cancer
Conditions
Interventions
experimental group (single arm):Pyrotinib in combination with Albumin–Bound Paclitaxel
Sponsors
Shandong Institute of Cancer Prevention and Control
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Local recurrence or metastasis breast cancer suitable for chemotherapy was confirmed by histology. 2. Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization) (ISH) positive (ISH amplification rate >= 2.0). 3. No chemotherapy has been carried out for recurrent and metastatic lesions, and local treatment for local symptoms is allowed, such as radiotherapy to relieve bone pain. 4. HER2 was positive in bilateral breast cancer patients. 5. Aged 18-70 years, female. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 7. Life expectancy greater than or equal to 12 weeks. 8. Patients with at least one measurable lesions by RECIST version 1.1. 9. Patients who had received trastuzumab and paclitaxel in the adjuvant stage and had a disease-free interval of >= 6 months from the end of trastuzumab use in the last adjuvant stage to tumor progression. 10. Endocrinotherapy is allowed in recurrent and metastatic stage. 11. Participants must have normal organ and marrow function as described below (1) Blood routine examination standards should be met a) Absolute neutrophil count >= 1.5 x 10^9/L; b) Platelets >= 75 x 10^9/L; c) Hemoglobin >= 100 g/L; (2) Liver and kidney function a) Total bilirubin = 50ml/min Left ventricular ejection fraction (LVEF) >= 50%. 12. Subjects joined the study voluntarily and signed the informed consent. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1.Confirmed by brain CT or MRI, the patient with brain tumor focus; Patients with only bone or skin as the only target focus 2.Inability to swallow, intestinal obstruction or other factors affecting drug use and absorption; 3.Patients who received radiotherapy, chemotherapy, surgical treatment (excluding local puncture) or molecular targeted treatment within 4 weeks before admission; Nitrosourea or mitomycin were given chemotherapy in the first 6 weeks; 4.Patients who are received anti-cancer endocrine therapy after the screening period; 5.Patients who had previously received Albumin–Bound Paclitaxel anti-cancer therapy; 6.Less than 4 weeks from the last clinical trial; 7.Previous or ongoing use of tyrosine kinase inhibitors targeting HER2 (Tykerb, Neratinib, Pyrrolidone, etc.). 8.Patients who had received antineoplastic therapy or radiotherapy for any malignant tumors, but excluding cured cervical cancer in situ, basal cell carcinoma or squamous cell carcinoma; 9.Patients are receiving anti-cancer therapy 10.Anyone with known history of allergy to the components of study drugs; history of immunodeficiency, including HIV positive, HCV, active hepatitis B or other acquired diseasesor other acquired or congenital immunodeficiency disorders, or history of organ transplantation; 11.Have suffered from any heart disease, including: (1) arrhythmia requiring drug treatment or clinical significance; (2) myocardial infarction; (3) heart failure; (4) any other heart disease judged by the investigator as unsuitable for the test; (5) angina pectoris. 12.Pregnant and lactating women, women with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole test period; 13.According to the judgment of the researchers, there are serious hazards to the safety of the patients, or the accompanying diseases that affect the completion of the study (including but not limited to severe hypertension, serious diabetes, active infection, etc., which cannot be controlled by the drugs); 14.Patients did not recover to grade 0-1 (except hair loss) from the toxic reaction of previous treatment; 15.History of psychiatric drugs abuse or patients with mental disorders; 16.Concomitant use of CYP3A4 inhibitors or inducers or ongoing use of drugs to extend QT interval 17.Researchers do not think it is suitable for inclusion. 18.Patients with previous hypersensitivity to paclitaxel .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;TTP;DOR;CBR;OS; | — |
Countries
China
Contacts
Public ContactHuihui Li
Shandong Institute of Cancer Prevention and Control
Outcome results
None listed