Advanced and Metastatic Breast Cancer
Conditions
Interventions
Group A:30mg UTD1+2000mg Capecitabine
Group B:2500mg Capecitabine
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer, lacking standard therapy or being failed to or recurrent after standard therapy; 2. Patients who have previously treated with less than 4 chemotherapeutic regimes; 3. Patients who have previously treated with an anthracyclin antibiotics and a taxane; 4. Age 18 -70 years old, ECOG performance status of 0-2; Life expectancy of 3 months or more; 5. Patients with at least 1 measurable target lesion determined by CT; 6. Neuropathy lower than CTC2 degree (NCI CTC4.03) within 4 weeks prior to enrollment; 7. Basically normal results from routine blood test within 1 week prior to enrollment; 8. Basically normal liver and renal functions within 1 week prior to enrollment; 9. No abnormal function for major internal organs, no heart diseases.
Exclusion criteria
Exclusion criteria: 1. Received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted drugs 4 weeks prior to enrollment, or received other chemotherapies while participating in this trial; 2. Patients with documented hypersensitivity to Cremophor EL, or patients with previous taxane treatment related SAE; 3. Patients of pregnancy or breast feeding; 4. Patients refractory to previous standard capecitabine treatment, or patients received effective standard capecitabine treatment with less than 6 months of capecitabine clearance period; 5. Patients with uncontrolled brain metastasis, bone metastasis, planned recent surgery or local radiotherapy, or other emergency patients; 6. Patients combined with severe and /or uncontrolled medical conditions, including severe cardiovascular disease, uncontrolled diabetes and high blood pressure, severe infection, severe gastrointestinal ulceration, and patients with incontrollable psychiatric history; 7. Patients with poor compliance; 8. Patients not fitted for this study determined by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactBinghe Xu
Outcome results
None listed