Triple negative breast cancer
Conditions
Interventions
Case series:Erlotinib combined with etoposide
Sponsors
Affiliated Tumor Hospital of Harbin Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18 to 75 years; 2. ECOG whole body state (PS) 0~2 level; 3. The expected survival period is not less than March; 4. Recurrent or metastatic triple-negative breast cancer diagnosed by histological or cytological methods. Three-negative breast cancer is defined as estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor (Her). -2) All were negative. If there is pathology of metastases, the histopathology of metastatic lesions shall prevail. ER and PR negative were defined as: ER =1.5xl0^9/L, platelets>=90x10^9/ L, hemoglobin >= 90g / L; ii. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT <= 2.5 x 40U / L, AST <= 2.5 x 35U / L, liver metastases ALT<= 5 x 40U/L, AST<=5 x 35U/L; total bilirubin (TBIL)<= 1.5 x 19umol/L; iii. Renal function: creatinine (Cr) <= 88 umol/L; 8. The patient gives informed consent and signs a written consent form. 9. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug; 10. Patient compliance is good, and follow-up, treatment, laboratory tests, and other research steps are voluntarily scheduled.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating woman 2. Known to be allergic to the drug or other ingredients contained in the test drug; 3. Symptomatic central system transfer. For patients with stable asymptomatic brain metastases who have received radiotherapy and at least one other measurable target lesion other than brain metastases, they may be enrolled, but more than four weeks from the last radiotherapy time; 4. Those who have had or have other malignant tumors at the same time. Except for those who have cured skin basal cell carcinoma and cervical carcinoma in situ; 5. Have received targeted therapy against HER-2, EGFR (eg, trastuzumab, panitumumab, cetuximab or its analogues, gefitinib, erlotinib, pull Patini, etc.); 6. Patients who have previously been treated with etoposide; 7. Patients who have progressed in anti-tumor vascular drug therapy; 8. The subject is currently enrolled in other studies, or is less than or equal to 4 weeks from other study medications; 9. Major surgery (if general anesthesia is required) within 4 weeks prior to enrollment, subjects must recover from surgery-related injuries; 10. Received transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to enrollment; 11. Clinically significant cardiovascular disease (defined as: unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] >=II), uncontrollable severe arrhythmia), enrolled Myocardial infarction occurred within the first 6 months; 12. According to the investigator's judgment, patients have other coexisting severe and/or poorly controlled medical conditions (such as uncontrolled hypertension, uncontrolled diabetes, clotting/hemorrhagic disease, etc.) that are prohibited from participating in this clinical study. ; 13. Have a history of interstitial lung disease (ILD), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI; 14. There are clinical symptoms, requiring clinical intervention or serous effusion (such as pleural effusion and ascites) with a stabilization time of less than 4 weeks; 15. A medical or psychiatric history or laboratory abnormal medical history that may interfere with the interpretation of the results; 16. A subject who is pregnant or breast-feeding, or who is scheduled to be pregnant during the treatment period and within 6 months after the end of treatment; 17. Subjects (including female subjects and/or male partners) who are unwilling to receive effective contraception during the treatment period and within 6 months after the end of treatment; 18. The subject is in the active period of hepatitis B or hepatitis C (has a history of hepatitis B infection, regardless of medication control, HBV DNA >= 10 ^ 3 copy number or >= 2000 IU / mL; hepatitis C infection, HCV RNA >= 15 IU / mL) Or human immunodeficiency virus (HIV) antibody-positive (if there is no clinical evidence suggesting that there may be HIV infection, no testing is required); 19. Subjects have active or uncontrolled infections (except for simple urinary tract infections or upper respiratory tract infections) requiring systemic treatment within 2 weeks or 2 weeks prior to enrollment; 20. Coagulation abnormalities (INR > 1.5 or PT > ULN + 4 seconds or APTT > 1.5 ULN), receiving thrombolytic or anticoagulant therapy, bleeding tendency, or clear gastrointestinal or other organ bleeding concern
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| size of the lesions; | — |
Countries
China
Contacts
Public ContactLu hailing
Affiliated Tumor Hospital of Harbin Medical University
Outcome results
None listed