Metastatic Breast Cancer
Conditions
Interventions
A:paclitaxel 175mg/m2 or docetaxel 120mg/m2 with thiotepa 175mg/m2
B:paclitaxel 175mg/m2 or docetaxel 75mg/m2 withthiotepa 75mg/m2
Sponsors
Beijing Cancer Hospital & Institute, Peking University School of Oncology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Breast cancer patients with metastatic or relapsed disease proved by histopathology or cytology; 2. Age between 18 and 70; 3. Measurable or evaluable disease, tumor mass >=10mm by ultrasonic examination, CT or MR scan; 4. ECOG Performance Status months; 5. An interval of at lest 4 weeks from the last operation, radiation therapy and chemotherapy; 6. With normal marrow function and the count of peripheral blood cell before treatment should in following range: WBC 4.0*10^9/L to 10*10^9/L, Hb 95g/L to 165g/L, PLT 75*10^9/L to 300*10^9/L; 7. Normal liver and kidney function tests; 8. Normal Electrocardiogram and no history of congestive heart failure; 9. No history of severe hypersensitive constitution and allergy to taxane; 10. Without active infection; 11. Patients with good compliance and accepting follow-up; 12. Inform of consents were signed voluntarily.
Exclusion criteria
Exclusion criteria: 1. Immeasurable tumor or only bone metastasis; 2. ECOG Performance Status > 2 and Expectant survival < 3 months; 3. Patients having operation, radiotherapy, chemotherapy within 4 weeks month; 4. Pregnant or lactated women; 5. History of congestive heart failure; 6. History of extensive pulmonary fibrosis or respiratory failure; 7. Dysfunction of liver or kidney (ALT, AST, Cr, and BUN raise over 1.5 times of upper limit of normal); 8. Aplastic marrow or marrow metastasis; 9. Active infection; 10. Patients with severe cerebrovascular disease or brain metastases that affect describing the state of illness; 11. Hypersensitive constitution or allergy to taxane.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, objective response rate, and adverse; | — |
Countries
China
Contacts
Public ContactDr. Jun Ren
Outcome results
None listed