Breast cancer
Conditions
Interventions
Case series:Doxorubicin Hydrochloride Liposome Injection, 40mg/m2, d1, 28 days a cycle, until disease progression
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Histopathologically proven HER2 negative (Definition: IHC 0 or 1+, or ISH negative, the HER2/CEP17 ratio < 2.0, or HER2 gene copy number < 4 by single probe CISH) relapsed or metastatic breast cancer; 3. Patients who have received at least 1 but no more than 4 prior lines of chemotherapy for relapsed or metastatic disease; 4. Patients who have previous used anthracyclines (e.g. doxorubicin, epirubicin) and taxanes (e.g. paclitaxel, docetaxel) by any combined or other drug deliver chemotherapy (including neoadjuvant or adjuvant chemotherapy and salvage treatment); 5. Measurable lesions; 6. ECOG performance status of 0-2; 7. Life expectancy of greater than or equal to 3 months; 8. Left ventricular ejection fraction (LVEF) =50%; 9. Bone marrow function: neutrophil count=1.5×10^9/L, platelet count=100×10^9/L, hemoglobin=90g/L; 10. Hepatic and renal function: TBIL, ALT, AST are less than or equal to ULN; due to liver metastasis, TBIL, ALT, AST are less than or equal to 5×ULN; serum creatinine is less than or equal to 1.5×ULN; 11. A negative serum or urine pregnancy test is required for women of child-bearing potential, highly effective methods of contraception must be applied during dosing of study treatment and for 3 months after the last dosage; 12. Sign the informed consent before any trial related activities.
Exclusion criteria
Exclusion criteria: 1. Patients who have congestive heart failure (New York Heart Association Class II or above); 2. Patients who have untreated brain metastases; 3. Patients who have severe systemic infection; 4. Patients who are known to be allergic or intolerant to pegylated liposomal doxorubicin or other related supplementary materials; 5. Patients who previous used doxorubicin and the cumulative dose is no less than 300mg/m2, or cumulative dose of epirubicin is no less than 550mg/m2; or had heart disease due to the use of anthracyclines; 6. Primary organ disfunction or disease: patients who have abnormal renal and liver function, history of heart attack, unstable heart diseases, and chronic active hepatitis, etc; 7. Patients with a history of other malignancies within the last 5 years (cured carcinoma of the cervix or skin basal cell carcinoma are excepted); 8. Patients who have received other anti-tumor therapy or other experimental drugs within the last 1 month; 9. Patients who are currently in another clinical trial; 10. Patients evaluated are not suitable for the study in the opinion of investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Countries
China
Contacts
Public ContactHuiping Li
Beijing Cancer Hospital
Outcome results
None listed