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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00083031 |
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of breast cancer by stopping blood flow to the tumor. Giving metronomic (regularly timed) low-dose cyclophosphamide and methotrexate together with bevacizumab may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying metronomic low-dose cyclophosphamide and methotrexate to see how well they work compared to metronomic low-dose cyclophosphamide, methotrexate, and bevacizumab in treating women with metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: bevacizumab Drug: cyclophosphamide Drug: methotrexate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Metronomic Chemotherapy in Combination With Bevacizumab for Advanced Breast Cancer |
Study Start Date: | November 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Patients in arm II who have progressive disease have the option of discontinuing treatment or crossing over to arm I.
PROJECTED ACCRUAL: A total of 36-66 patients (18-33 per treatment arm) will be accrued for this study within 7-12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed invasive breast cancer
Measurable disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent anticoagulation or chronic aspirin therapy (> 325 mg/day)
Concurrent bisphosphonates allowed provided skeletal sites are not the primary sites used in assessing response
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Harold J. Burstein, MD, PhD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000361807, DFCI-03083 |
Study First Received: | May 14, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00083031 History of Changes |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IV breast cancer |
Antimetabolites Skin Diseases Immunologic Factors Folate Breast Neoplasms Cyclophosphamide Bevacizumab Folinic Acid Folic Acid Antagonists Angiogenesis Inhibitors |
Immunosuppressive Agents Vitamin B9 Recurrence Folic Acid Methotrexate Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Cyclophosphamide Reproductive Control Agents Neoplasms by Site Therapeutic Uses Abortifacient Agents Methotrexate Growth Inhibitors Angiogenesis Modulating Agents |
Alkylating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Breast Diseases Skin Diseases Growth Substances Breast Neoplasms Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists |