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
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
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 Colorado | Denver, Colorado 80217 |
| Sioux Valley Clinic | Sioux Falls, South Dakota 57104 |
| John B. Amos Cancer Center | Columbus, Georgia 31904 |
| Tennessee Cancer Specialists | Knoxville, Tennessee 37920 |
| Osceola Cancer Center | Kissimmee, Florida 34741 |
| Hematology Oncology Consultants, Inc. | Columbus, Ohio 43235 |
| Hematology & Oncology Associates of NEPA | Dunmore, Pennsylvania 18512 |
| Scripps Cancer Center Clinical Research | San Diego, California 92121 |
| Northwest Hematology/Oncology Associates | Coral Springs, Florida 33065 |
| UM/Sylvester Cancer Center | Plantation, Florida 33324 |
| Clintell, Inc | Skokie, Illinois 60076 |
| Hutchinson Clinic P.A. | Hutchinson, Kansas 67502 |
| Western Maryland Health System | Cumberland, Maryland 21502 |
| Brody School of Medicine @ ECU | Greenville, North Carolina 27834 |
| Aultman Hospital Cancer Center | Canton, Ohio 44710 |
| Vita Hematology Oncology | Bethlehem, Pennsylvania 18015 |
| PA Oncology Hematology Asso | Philadelphia, Pennsylvania 19106 |
| M. Francisco Gonzalez | Columbia, South Carolina 29203 |
