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Anastozole

Phase 3

Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 6, 2012

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9,358
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00849030ATAC - Arimidex, Tamoxifen Alone or in CombinationPHASE3 COMPLETED 9,358Jul 1, 1996Apr 1, 2010Jun 6, 2012 -
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Study Endpoints
Primary Endpoints
Time to recurrence of breast cancer
Earliest of local or distant recurrence, new primary breast cancer, or death
Safety and side effects
Earliest of local or distant recurrence, new primary breast cancer, or death
Secondary Endpoints
Time to distant recurrence
Earliest of local or distant recurrence, new primary breast cancer, or death
Survival
Earliest of local or distant recurrence, new primary breast cancer, or death
New breast primaries
Earliest of local or distant recurrence, new primary breast cancer, or death
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORArimidex 1mg + Nolvadex placebo
2ACTIVE_COMPARATORArimidex placebo + Nolvadex 20mg
3ACTIVE_COMPARATORArimidex 1mg + Nolvadex 20mg
Interventions
NameTypeDescription
Anastozole (Arimidex)DRUG1mg, orally, once daily
Tamoxifen (Nolvadex)DRUG20mg, orally, once daily
Anastozole (Arimidex) placeboDRUG1mg, orally, once daily
Tamoxifen (Nolvadex) placeboDRUG20mg, orally, once daily
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Eligibility Criteria
Age Range45 Years — N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Patients with histologically proven operable invasive breast cancer * Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy * Women defined as post-menopausal Exclusion Criteria: * Patients in who...

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Competitive Landscape -Breast Cancer 408 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib, Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy, Imlunestrant, Tamoxifen, Anastrozole
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1, Capecitabine, Paclitaxel, Nab-paclitaxel
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib, Alpelisib, Fulvestrant, Trastuzumab, Pertuzumab
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant, PF-07220060, letrozole, abemaciclib
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib, Arm A: Gedatolisib + Palbociclib + Fulvestrant
Relay Therapeutics, Inc.RLAY2PHASE3RLY-2608, Capivasertib, Fulvestrant, Palbociclib, Ribociclib
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
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
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam, Alisertib, Endocrine therapy
Immutep Ltd Sponsored ADRIMMP1PHASE2eftilagimod alpha, Paclitaxel
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