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UTD1 plus capecitabine

Phase 3

Breast Cancer | Small Molecules | Oncology |Biostar Pharmaceuticals, Inc.|Trials Updated: Apr 9, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment405

FDA Designations

No designations recorded

UTD1 plus capecitabine clinical trials

UTD1 plus capecitabine · 1 trial · 1 indication

Phase 3 1
NCT02253459Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast CancerBreast Cancer
COMPLETED405 Analytics
PHASE3COMPLETED
Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progresssion free survival (PFS)
2.0 years

Secondary Endpoints

Overall survival (OS)
4 years
Objective Response Rate(ORR)
1.5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
UTD1 Injection plus capecitabineEXPERIMENTALUTD1 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.
capecitabineACTIVE_COMPARATORCapecitabine: 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.

Interventions

NameTypeDescription
UTD1 Injection plus capecitabineDRUG -
CapecitabineDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites11

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 pr...

Countries:China
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Competitive Landscape -Breast Cancer 601 trials

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