Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Drug: UTD1 Injection plus capecitabine
- Registration Number
- NCT02253459
- Lead Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 405
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description capecitabine Capecitabine 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. UTD1 Injection plus capecitabine UTD1 Injection plus capecitabine 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.
- Primary Outcome Measures
Name Time Method Progresssion free survival (PFS) 2.0 years
- Secondary Outcome Measures
Name Time Method Overall survival (OS) 4 years Objective Response Rate(ORR） 1.5 years
Trial Locations
- Locations (11)
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The General Hospital of the People's Liberation Army
🇨🇳Beijing, Beijing, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Sir Run Run Shaw Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
The Hospital Affiliated To Military Medical Science
🇨🇳Beijing, Beijing, China
the First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China