Clincosm LogoSign in Get a demo

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

Sponsor
Beijing Biostar Technologies, Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT02253459
Collaborator
(none)
405
Enrollment
11
Locations
2
Arms
52.5
Actual Duration (Months)
36.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
405 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Clinical Trials of UTD1 Injection Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced and Metastatic Breast Cancer
Actual Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Dec 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: UTD1 Injection plus capecitabine
Active Comparator: 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.

Drug: Capecitabine

Outcome Measures

Primary Outcome Measures

  1. Progresssion free survival (PFS) [2.0 years]

Secondary Outcome Measures

  1. Overall survival (OS) [4 years]

  2. Objective Response Rate(ORR） [1.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing China 100021
2 The Hospital Affiliated To Military Medical Science Beijing Beijing China 100071
3 The General Hospital of the People's Liberation Army Beijing Beijing China 100853
4 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060
5 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150081
6 Henan Cancer Hospital Zhengzhou Henan China 450008
7 the First Hospital of China Medical University Shenyang Liaoning China 110001
8 Liaoning Cancer Hospital & Institute Shenyang Liaoning China 110042
9 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200433
10 Sir Run Run Shaw Hospital Hangzhou Zhejiang China 310016
11 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022

Sponsors and Collaborators

  • Beijing Biostar Technologies, Ltd

Investigators

  • Principal Investigator: B Xu, doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Biostar Technologies, Ltd
ClinicalTrials.gov Identifier:
NCT02253459
Other Study ID Numbers:
  • BG01-1323L
First Posted:
Oct 1, 2014
Last Update Posted:
Apr 9, 2019
Last Verified:
Apr 1, 2019
Additional relevant MeSH terms:
Breast Neoplasms
Capecitabine

Study Results

No Results Posted as of Apr 9, 2019