breast cancer
Conditions
Interventions
Case series:Conventional chemotherapy (TH regimen) combined with KN035 5mg/kg/3w
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. signed the informed consent; 2. female aged between 18 and 70 years; 3. patients with histological diagnosed HER2-positive breast cancer with recurrence or distant metastasis; 4. LVEF basement >=50%; 5. No previous use of docetaxel or previous neoadjuvant / adjuvant therapy with docetaxel should be completed at least 12 months before diagnosis of disease recurrence / metastasis; 6. has not received Herceptin treatment or has not been diagnosed primary Herceptin resistant bisphosphonate treatment before; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 8. The expecting span>=12 weeks; 9. patients with good organ function and are not contraindicated with azolidronic acid and meet the following indicators: Hb =90 g/L; WBC =4.0 x 10^9/L; Platelet =100 x 10^9/L; Neutrophilic granulocytes =1.5×10^9/L; AST and ALT no more than 1.5 times the normal upper limit; Bilirubin no more than 1.5 times the normal upper limit; AKP no more than 2.5 times the normal upper limit; Serum creatinine no more than 1.5 times the normal upper limit or Clearance rate of creatinine >60ml/min; 10. Non-surgical sterilization or childbearing age women, during the treatment and research within 3 months after the end of the treatment period using an approved by the medical contraception (such as intrauterine device, the pill or condoms); Non-surgical sterilization period women of childbearing age in research into the group of 72 h before the serum or urine HCG test must be negative; And must be not for the nursing.
Exclusion criteria
Exclusion criteria: 1. Participants with any active or history of autoimmune diseases which without alternative treatment (including but not limited to: autoimmune hepatitis, interstitial pneumoniauveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; participants with vitiligo, or asthma with completely relief during childhood without any additional medicine interventions in adulthood are recruited; participants with asthma under bronchodilator therapy are excluded; 2. Participants who are taking immunosuppressant drugs or under systematic therapy to maintain immunosuppressive status (dosage>10mg/day prednione or equivalent agents), within 2 weeks before recruitments; 3. With accumulated dosage of anthracyclines during previous neo-adjuvant chemotherapy or adjuvant chemotherapy: doxorubicin>400 mg/m2, or epirubicin>800 mg/m2, or equivalent dosages (or based on comprehensive judgements of previous therapiesmade by researchers); 4. With allergy to Trastuzumab, docetaxel and other trial agents, or murine proteins, humanized proteins, or any formulation ingredients. Or with history of allergic diseases or allergic constitution; 5. Central nerve systematic metastasis with clinical symptoms (eg. Brain edema, in need of corticosteroid intervention, or progressive brain metastasis). Participants with previous therapy on brain or brain metastasis, if clinical stability (MRI) maintained, for at least 1 month, without receiving additional systematic corticosteroid therapy (dosage>10 mg/day prednione or equivalent agents) for 2 weeks, are included; 6. With hypertension, and hypotension drugs failed to maintain proper blood pressure control (systolic pressure=140 mmHg or diastolic pressure=90 mmHg; 7. With heart diseases or clinical symptoms, eg.: (1) heart failure above HYHA level; (2) unstable angina; (3) myocardial infarction within 1 year; (4) superventricular arrhythmia or ventricular arrhythmia with clinical significance and in need of interventions; 8. With Coagulation abnormalities (PT>16sAPTT>43sTT>21sFbg=++, or quantitative of ptoteinuria>=1.0 g in 24 hour; 10. After radiation therapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy within 4 weeks before the study; adverse events (except for hair loss) caused by previous treatmen have not recovered to CTCAE 1 degrees or less; 11. within 3 months before enrollment have significant clinical significance of bleeding symptoms or have definite bleeding tendency, such as daily haemoptysis 2.5 ml and above, gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of defecate occult blood, or with vasculitis; 12. Arterial or venous thrombosis events, eg cerebrovascular accident (including transient cerebral ischemiatransient cerebral ischemiacerebral infarction) deep venous thrombosis or pulmonary embolism within 6 months before erollment; 13. Known inherited or acquired bleeding tendency and thrombosis (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, the splenic function, etc.); 14. Subjects had active infection (CTCAE > 2); 15. Subjects ha innate or acquired immune function defects (such as HIV infection), or active hepatitis; 16. Subjects participated other drug clinical trials within 4 weeks before the study; 17. Subjects have other malignant tumors within 5 years or at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event Rate;Disease Control Rate;Progression Free Survival; | — |
Countries
China
Contacts
Public ContactErwei Song
Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed