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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

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Myocet · 1 trial · 1 indication

Phase 3 1
NCT02214381A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low ResponseEarly Primary Breast Cancer
COMPLETED80 Analytics
PHASE3COMPLETED
A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response
Early Primary Breast CancerUnlock trial analytics

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 to 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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Frequently asked questions about Myocet

What is Myocet used for in early primary breast cancer?

Myocet is an investigational small molecule being studied for the treatment of early primary breast cancer. It is currently in Phase 3 clinical development. The drug is being evaluated in a neoadjuvant setting, meaning it is given before primary treatment, in a completed clinical trial.

Who makes Myocet?

Myocet is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical research on the drug for the oncology therapeutic area, specifically targeting early primary breast cancer.

What phase is Myocet in?

Myocet is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied for early primary breast cancer. The Phase 3 trial has been completed, with results expected to inform further development.

What clinical trials is Myocet in?

Myocet is associated with one completed Phase 3 clinical trial, identified as NCT02214381. This was a prospective, multicenter, open-label 12-week neoadjuvant trial in elderly patients with low response, enrolling 80 female patients aged 70 years and older in Germany.

Is Myocet the same as any other drug?

Myocet is a distinct drug candidate developed by Teva Pharmaceutical Industries Limited. No alternative names for Myocet have been established in the available clinical trial information. It is being studied specifically for early primary breast cancer.