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West Cancer Center
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BREAST: Metastatic: TNBC: 2nd or later line; Phase 1; "D4884C00001 TNBC"

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors

Title
AstraZeneca D4884C00001 TNBC
Study Title
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors
Site Link
NCT02527434
Malignancy
Breast, Metastatic Triple Negative Breast Cancer
Stage
Stage 4
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd, 3rd, 4th line
Investigational Agent
Tremelimumab (and Durvalumab)
Drug Class
anti CTLA-4 antibody (and anti PD-L1 antibody)
PI
Ari VanderWalde, MD, MPH
Sponsor
AstraZeneca
Phase
Phase 1
Status
Closed to Accrual
Key Eligibility Criteria
NCT02527434
Key Eligibility Criteria Details

    • Metastatic Triple-Negative Breast Cancer

    • Failed at least one line of therapy in metastatic setting

    • No more than 3 previous lines of therapy in the metastatic setting

    • Measurable disease

    • No prior autoimmune or inflammatory disorders

    • No CNS involvement or history of spinal cord compression

Objective
Primary- ORR; Secondary- BOR, DoR, DCR, PFS, OS, Safety
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
ER negative, PR negative, HER2 negative
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
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