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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Principal Investigator

Jose Baselga, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vall d'Hebron Hospital, Barcelona, Spain

Authority:

United States: Food and Drug Administration

Study ID:

STM01-102

NCT ID:

NCT00294996

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic Her2+ Breast cancer
  • Myocet
  • liposomal doxorubicin
  • trastuzumab
  • Breast Neoplasms

Name

Location

University of ColoradoDenver, Colorado  80217
Sioux Valley ClinicSioux Falls, South Dakota  57104
John B. Amos Cancer CenterColumbus, Georgia  31904
Tennessee Cancer SpecialistsKnoxville, Tennessee  37920
Osceola Cancer CenterKissimmee, Florida  34741
Hematology Oncology Consultants, Inc.Columbus, Ohio  43235
Hematology & Oncology Associates of NEPADunmore, Pennsylvania  18512
Scripps Cancer Center Clinical ResearchSan Diego, California  92121
Northwest Hematology/Oncology AssociatesCoral Springs, Florida  33065
UM/Sylvester Cancer CenterPlantation, Florida  33324
Clintell, IncSkokie, Illinois  60076
Hutchinson Clinic P.A.Hutchinson, Kansas  67502
Western Maryland Health SystemCumberland, Maryland  21502
Brody School of Medicine @ ECUGreenville, North Carolina  27834
Aultman Hospital Cancer CenterCanton, Ohio  44710
Vita Hematology OncologyBethlehem, Pennsylvania  18015
PA Oncology Hematology AssoPhiladelphia, Pennsylvania  19106
M. Francisco GonzalezColumbia, South Carolina  29203