Status:
COMPLETED
Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer
Lead Sponsor:
Beijing Biostar Pharmaceuticals Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2018
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT02253459
Start Date
August 1 2014
End Date
December 15 2018
Last Update
April 9 2019
Active Locations (11)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
The Hospital Affiliated To Military Medical Science
Beijing, Beijing Municipality, China, 100071
3
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China, 100853
4
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060