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RAD001, Letrozole

Phase 2

Breast Neoplasm | Small molecule | Oncology |Novartis AG|Last Updated: Mar 4, 2013

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment267
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00107016Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal WomenPHASE2 COMPLETED 267 — — Mar 1, 2005Apr 1, 2007Mar 4, 201346 United States, Austria +8
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Study Endpoints
Primary Endpoints
To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women
Secondary Endpoints
To assess the four month treatment as being predictive of clinical tumor response
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RAD001 + letrozole 2.5mgEXPERIMENTAL -
Letrozole 2.5mgACTIVE_COMPARATOR -
Interventions
NameTypeDescription
RAD001, Letrozole 2.5mgDRUG -
Letrozole 2.5mgDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites46

Inclusion Criteria: * Histologically-confirmed diagnosis of invasive breast cancer, previously untreated * Patients must be postmenopausal * Candidates for mastectomy or breast-conserving surgery * Primary tumor of above 2 cm diameter, measured by imaging * Clinical Stage M0 * WHO performance statu...

Countries:United StatesAustriaBelgiumCanadaFranceGermanyItalyRussiaSpainUnited Kingdom
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