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BIIB021

Phase 2

Breast Cancer | Small molecule | Oncology |Biogen Inc.|Last Updated: Oct 2, 2015

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01004081Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule FindingPHASE2 COMPLETED 54 — — Nov 1, 2009Oct 1, 2011Oct 2, 201534 United States, Australia +2
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Study Endpoints
Primary Endpoints
The primary objective of this study is to assess the efficacy of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal AI.
As specified in protocol
Secondary Endpoints
The secondary objective of this study is to evaluate the safety and tolerability of BIIB021 in combination with exemestane in this study population.
As specified in protocol
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BIIB021 BID + exemestaneEXPERIMENTALBIIB021 100 mg BID + exemestane 25 mg QD
BIIB021 TIW + exemestaneEXPERIMENTALBIIB021 450 mg TIW + exemestane 25 mg QD
Interventions
NameTypeDescription
BIIB021DRUGBID orally for 28 days
exemestane (Aromasin)DRUGDaily in tablet form for 28 days
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * Age 18 years of age * Must have histologically or cytologically confirmed estrogen receptor- positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer. * Must have disease progression during treatment with a nonsteroidal AI for locall...

Countries:United StatesAustraliaBelgiumRussia
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Competitive Landscape -Breast Cancer 408 trials
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BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib, Pembrolizumab, Axatilimab
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
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Immutep Ltd Sponsored ADRIMMP1PHASE2eftilagimod alpha, Paclitaxel
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