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Myocet

Phase 1

Breast Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Mar 6, 2023

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment73
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00129896Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer PatientsPHASE1 COMPLETED 73 — — Jan 1, 2004Feb 1, 2010Mar 6, 202316 Spain
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Study Endpoints
Primary Endpoints
Tolerability (Phase I): Recommended Doses of the combination treatment
up to 24 months since last patient included in the Phase I

Recommended Doses of the combination treatment

Efficacy (Phase II): Percentage (%) pathological Complete Response achieved according to Miller and Payne Criteria
up to 24 months since last patient included in the Phase II

% pathological Complete Response achieved according to Miller and Payne Criteria

Secondary Endpoints
Clinical response rates
up to 6 months since last patient treatment
Surgery type (conservative surgery versus mastectomy)
up to 7 months since last patient treatment
Potential cardiac toxicity
up to 12 months since last patient included
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Myocet+Taxotere+HerceptinEXPERIMENTALMyocet 50 mg/m2; Taxotere 60 mg/m2; Herceptín 4 mg/Kg (first dose) and in the following cycles 2 mg/Kg
Interventions
NameTypeDescription
MyocetDRUGMyocet®: 60-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles
TaxotereDRUGTaxotere® 70-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles
HerceptinDRUGHerceptin® (4) 2 mg/kg (vía IV) Semanal for 6 cycles
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Eligibility Criteria
Age Range18 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Written informed consent. * Breast cancer stages II and IIIA with histological diagnoses by true-cut. * Breast cancer tumours overexpressing HER2neu, centrally confirmed by FISH. * No evidence of metastasis: bilateral mammography, thorax x-ray, computed tomography (CT)-scan or...

Countries:Spain
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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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