Trial of Myocet in Metastatic Breast Cancer

A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00294996

Enrollment

363

Registered

2006-02-22

Start date

2006-01-31

Completion date

Unknown

Last updated

2009-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Metastatic Her2+ Breast cancer, Myocet, liposomal doxorubicin, trastuzumab

Brief summary

The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.

Interventions

DRUGMyocet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Metastatic Her2+ Breast cancer by FISH analysis * No prior chemotherapy for metastatic disease * Measurable disease * normal left ventricular ejection fraction

Exclusion criteria

* prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2 * relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival	—

Secondary

Measure	Time frame
Overall Survival	—
Safety	—

Countries

Argentina, Canada, Germany, India, Italy, Poland, Portugal, Russia, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026