Trial of Myocet in Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by Sopherion Therapeutics. Recruitment status was Active, not recruiting

First Received on February 17, 2006. Last Updated on March 30, 2009 History of Changes

Sponsor:	Sopherion Therapeutics
Information provided by:	Sopherion Therapeutics
ClinicalTrials.gov Identifier:	NCT00294996

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Myocet	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Myocet Trastuzumab

U.S. FDA Resources

Further study details as provided by Sopherion Therapeutics:

Primary Outcome Measures:

Progression-Free Survival

Secondary Outcome Measures:

Overall Survival
Safety

Enrollment:	363
Study Start Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294996

Show 105 Study Locations

Sponsors and Collaborators

Sopherion Therapeutics

Investigators

Principal Investigator:

Jose Baselga, M.D.

Vall d'Hebron Hospital, Barcelona, Spain

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00294996 History of Changes
Other Study ID Numbers:	STM01-102
Study First Received:	February 17, 2006
Last Updated:	March 30, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sopherion Therapeutics:

Metastatic Her2+ Breast cancer
Myocet
liposomal doxorubicin
trastuzumab

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin

Trastuzumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012