Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer

Inclusion criteria

• Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer,or lacking standard therapy or being failed to or recurrent after standard therapy;
• Patients who have previously treated with ≤4 chemotherapeutic regimes;
• Patients who have previously treated with an anthracyclin antibiotics and a taxane;
• Age 18 -70 years old, ECOG performance status of 0-2; Life expectancy of 3 months or more;
• Patients with at least 1 measurable target lesion determined by CT within 2 weeks prior to enrollment;
• Neuropathy <CTC2 degree （NCI CTC4.03）within 4 weeks prior to enrollment;
• Basically normal results from routine blood test within 1 week prior to enrollment;
• Basically normal liver and renal functions within 1 week prior to enrollment;
• No abnormal function for major internal organs, no heart diseases.

Exclusion criteria

• Received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted drugs 4 weeks prior to enrollment, or received other chemotherapies while participating in this trial;
• Patients with documented hypersensitivity to Cremophor EL, or patients with previous taxane treatment related SAE;
• Patients of pregnancy or breast feeding;
• Patients with previous standard capecitabine treatment ineffective, or patients received standard capecitabine treatment effective, but with less than 6 months of capecitabine clearance period;
• Patients with uncontrolled brain metastasis or bone metastasis, which plan for recent surgery or local radiotherapy, or other emergency treatment;
• 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;
• Patients with poor compliance;
• Patients not fitted for this study determined by the investigators.