Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments utd1 injection plus capecitabine, capecitabine
Phase phase 3
Sponsor Beijing Biostar Technologies, Ltd
Start date August 2014
End date December 2016
Trial size 405 participants
Trial identifier NCT02253459, BG01-1323L

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
utd1 injection plus capecitabine
(Active Comparator)
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.
capecitabine

Primary Outcomes

Measure
Progresssion free survival (PFS)
time frame: 2.0 years

Secondary Outcomes

Measure
Overall survival (OS)
time frame: 4 years
Objective Response Rate(ORR)
time frame: 1.5 years

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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 <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: 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.

Additional Information

Official title Phase III Clinical Trials of UTD1 Injection Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced and Metastatic Breast Cancer
Principal investigator B Xu, doctor
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Beijing Biostar Technologies, Ltd.