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Myocet

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

Myocet · 1 trial · 1 indication

Phase 1 1
NCT00129896Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer PatientsBreast Cancer
COMPLETED73 Analytics
PHASE1COMPLETED
Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer Patients
Breast CancerUnlock trial analytics

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 to 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 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
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
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Myocet

What is Myocet used for in breast cancer?

Myocet is an investigational small molecule being studied for the treatment of breast cancer. It is being evaluated in the neoadjuvant setting for HER2 positive breast cancer patients, meaning it is given before surgery to shrink tumors. The drug is currently in Phase 1 clinical development.

Who makes Myocet?

Myocet is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting clinical research to evaluate the drug's safety and efficacy in breast cancer patients.

What phase is Myocet in?

Myocet is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug remains under investigation for its potential use in breast cancer.

What clinical trials is Myocet in?

Myocet has been studied in one completed clinical trial, identified as NCT00129896. This Phase 1 trial, titled 'Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer Patients,' enrolled 73 female participants aged 18 years and older in Spain.

What does Myocet target?

Myocet is a small molecule being studied in breast cancer. The specific molecular target of Myocet has not been disclosed in the available clinical trial information. The completed trial focused on HER2 positive breast cancer patients, but the drug's mechanism of action is not specified.