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lapatinib ditosylate

Phase 3

Breast Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Mar 21, 2025

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment652
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00667251Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast CancerPHASE3 COMPLETED 652 — — Oct 7, 2008Jul 27, 2022Mar 21, 2025257 United States, Argentina +19
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Study Endpoints
Primary Endpoints
Progression Free Survival (PFS) at the Time of Primary Results
From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months

Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.

Secondary Endpoints
Progression Free Survival (PFS) at the Time of Final Analysis
From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 45 months
Overall Survival (OS) (IIT Population)
From date of randomization until date of death from any cause, assessed up approximately 165 months
Overall Survival (OS) (Central HER2+ Population)
From date of randomization until date of death from any cause, assessed up approximately 165 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LapatinibACTIVE_COMPARATORPlus taxane based chemotherapy
TrastuzumabACTIVE_COMPARATORPlus taxane based chemotherapy.
Interventions
NameTypeDescription
trastuzumabBIOLOGICALIV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).
docetaxelDRUG75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).
lapatinib ditosylateDRUG1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion).
paclitaxelDRUG80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites257

Key inclusion criteria: * Histologically confirmed adenocarcinoma of the breast. * MBC (stage IV) at primary diagnosis or at relapse after curative intent therapy. * Local or central laboratory confirmed HER2/neu overexpressing and/or amplified disease in the invasive component of the primary or me...

Countries:United StatesArgentinaAustraliaBelgiumCanadaFranceGermanyIndiaIsraelItalyJapanMexicoNetherlandsPolandRussiaSouth KoreaSpainTaiwanThailandUkraineUnited Kingdom
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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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