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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00217672 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether giving docetaxel together with bevacizumab is more effective than docetaxel alone in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with bevacizumab works compared to docetaxel alone as first-line therapy in treating women with stage IV breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: bevacizumab Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Randomized Phase II Trial of Docetaxel With or Without Bevacizumab as First-Line Therapy for HER2-Negative Metastatic Breast Cancer |
Estimated Enrollment: | 150 |
Study Start Date: | April 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to prior adjuvant and/or neoadjuvant chemotherapy (none vs prior chemotherapy without a taxane vs prior chemotherapy with a taxane). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed within 30 days and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study within 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Meets 1 of the following criteria:
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Prior adjuvant chemotherapy allowed
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 |
Study Chair: | John A. Glaspy, MD, MPH | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000442877, UCLA-0501049-01, TORI-B-01 |
Study First Received: | September 20, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00217672 |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer |
Docetaxel Skin Diseases Breast Neoplasms |
Bevacizumab Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |