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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00047255 |
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. It is not yet known if docetaxel and trastuzumab are more effective with or without carboplatin in treating women who have HER2-positive breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of combining docetaxel and trastuzumab with or without carboplatin in treating women who have HER2-positive stage IIIB or stage IV breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Drug: carboplatin Drug: docetaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | A Multicenter Phase III Randomized Trial Comparing Docetaxel (Taxotere) and Trastuzumab (Herceptin) With Docetaxel (Taxotere), Carboplatin and Trastuzumab (Herceptin) as First Line Chemotherapy for Patients With Advanced Breast Cancer Containing the HER2 Gene Amplification |
| Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to prior adjuvant and/or neoadjuvant chemotherapy (none vs with taxanes vs without taxanes) and participating center. Patients are randomized to 1 of 2 treatment arms.
Arm I:
Patients are followed every 2 months for 3 years.
PROJECTED ACCRUAL: A total of 444 patients (222 per treatment arm) will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
Measurable or evaluable disease
None of the following are eligible as only manifestation of metastatic disease:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No other prior or concurrent malignancy except for:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent bisphosphonates if osteolytic bone metastases are only site of disease
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095 | |
| Ireland | |
| St. Vincent's University Hospital | |
| Dublin, Ireland, 4 | |
| Principal Investigator: | Linnea Chap, MD | C. Klien and Associates |
More Information
| Study ID Numbers: | CDR0000257580, UCLA-0109024, BCIRG-007, ROCHE-UCLA-0109024, GENENTECH-UCLA-0109024, NCI-G02-2116 |
| Study First Received: | October 3, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00047255 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent breast cancer |
|
Docetaxel Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Trastuzumab Breast Neoplasms Carboplatin Pharmacologic Actions Breast Diseases |