Overview

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

Status:
Completed
Trial end date:
2018-12-15
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Biostar Technologies, Ltd
Treatments:
Capecitabine
Criteria
Inclusion Criteria:

1. Histologically and/or cytologically diagnosed patients with advanced, metastatic
breast cancer,or lacking standard therapy or being failed to or recurrent after
standard therapy;

2. Patients who have previously treated with ≤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 within 2 weeks
prior to enrollment;

6. Neuropathy
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:

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 with previous standard capecitabine treatment ineffective, or patients
received standard capecitabine treatment effective, but with less than 6 months of
capecitabine clearance period;

5. Patients with uncontrolled brain metastasis or bone metastasis, which plan for recent
surgery or local radiotherapy, or other emergency treatment;

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.