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Myocet

Phase 3

Early Primary Breast Cancer | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Feb 27, 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
ACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02214381A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low ResponsePHASE3 COMPLETED 80 — — Jul 1, 2014Jan 15, 2025Feb 27, 20252 Germany
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Study Endpoints
Primary Endpoints
Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2).
After 5 years of follow-up.
Secondary Endpoints
Incidence of febrile neutropenia (FN) after 1 x MC in patients with primary prophylaxis (PP) vs. others.
After 5 years of follow-up.
Toxicity in the 4 x MC versus 2 x MC followed 6 x Pac arm as measured by adverse events.
After 5 years of follow-up.
Number of pCR in non-responders to MC.
After 5 years of follow-up.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mycet/CyclophosphamidACTIVE_COMPARATOR4 x Myocet 60 mg/m² q3w in combination with 4 x cyclophosphamide 600 mg/m² q3w depending on early response assessment by ultrasound or on toxicity profile.
Myocet/Cyclophosphamide/PaclitaxelACTIVE_COMPARATOR2 x Myocet 60 mg/m² q3w in combination with 2 x cyclophosphamide 600 mg/m² q3w followed by 6 x paclitaxel 80 mg/m² q1w depending on early response assessment by ultrasound or on toxicity profile.
Interventions
NameTypeDescription
MyocetDRUG -
CyclophosphamideDRUG -
PaclitaxelDRUG -
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Eligibility Criteria
Age Range70 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites2

General Inclusion Criteria for ADAPT: * Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly) * Candidate for chemotherapy on the basis of conventional criteria * Histologically confirmed unilateral primary invasive carcinoma of the breast ...

Countries:Germany
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