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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether UTD1 Injection in combination with capecitabine is effective in the treatment of advanced metastatic breast cancer using capecitabine as a control.

Official Title
-----------------
Phase III Clinical Trials of UTD1 Injection Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced and Metastatic Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: UTD1 Injection plus capecitabine
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UTD1 Injection plus capecitabine<br>UTD1 Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle; Capecitabine: 2000 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. | Drug: UTD1 Injection plus capecitabine<br> <br> |
| Active Comparator: capecitabine<br>Capecitabine: 2500 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. | Drug: Capecitabine<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progresssion free survival (PFS) |  | 2.0 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 4 years | 
| Objective Response Rate(ORR） |  | 1.5 years |