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

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ClinicalTrials.gov Identifier: NCT02253459
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Biostar Technologies, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: UTD1 Injection plus capecitabine Drug: Capecitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : August 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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



Primary Outcome Measures :
  1. Progresssion free survival (PFS) [ Time Frame: 2.0 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 4 years ]
  2. Objective Response Rate(ORR) [ Time Frame: 1.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 <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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253459


Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
The Hospital Affiliated To Military Medical Science
Beijing, Beijing, China, 100071
The General Hospital of the People's Liberation Army
Beijing, Beijing, China, 100853
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China, Heilongjiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
China, Henan
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
China, Liaoning
the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110042
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200433
China, Zhejiang
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310016
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Beijing Biostar Technologies, Ltd
Investigators
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Principal Investigator: B Xu, doctor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beijing Biostar Technologies, Ltd
ClinicalTrials.gov Identifier: NCT02253459    
Other Study ID Numbers: BG01-1323L
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents