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LY353381

Phase 3

Breast Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jul 19, 2006

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00034125Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.PHASE3 COMPLETED - - -Jul 19, 200611 United States, Argentina +3
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
LY353381DRUG -
tamoxifenDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites11

Inclusion Criteria 1. Locally advanced or metastatic breast cancer 2. Bi-dimensionally measurable disease Exclusion Criteria 1\. Prior hormonal therapy

Countries:United StatesArgentinaChileIndiaMexico
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