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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004888 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without trastuzumab in treating women who have metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Drug: docetaxel Drug: pegylated liposomal doxorubicin hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Safety and Efficacy Study of Doxil and Taxotere +/- Herceptin in Advanced Breast Cancer |
| Study Start Date: | October 2000 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are assigned to one of two treatment arms according to HER2 overexpression status.
Patients may receive maintenance therapy of docetaxel IV over 1 hour either weekly or every 3 weeks. Maintenance continues in the absence of disease progression or unacceptable toxicity.
Patients may receive maintenance therapy of trastuzumab IV over 30 minutes weekly followed by docetaxel IV over 1 hour weekly or every 3 weeks. Maintenance continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 92 patients (46 per arm) will be accrued for this study within 13 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable or evaluable disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Tufts - New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Robert Wood Johnson University Hospital | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, New York | |
| Albert Einstein Clinical Cancer Center | |
| Bronx, New York, United States, 10461 | |
| MBCCOP-Our Lady of Mercy Cancer Center | |
| Bronx, New York, United States, 10466 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Pennsylvania | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Lankenau Cancer Center at Lankenau Hospital | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Wisconsin | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
| Green Bay, Wisconsin, United States, 54307-3453 | |
| South Africa | |
| Pretoria Academic Hospital | |
| Pretoria, South Africa, 0001 | |
| Study Chair: | Antonio C. Wolff, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000067564, ECOG-3198 |
| Study First Received: | March 7, 2000 |
| Last Updated: | May 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004888 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
Docetaxel Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Trastuzumab Breast Neoplasms Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Breast Diseases |