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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00119262 |
RATIONALE: 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 blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with more than one chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: bevacizumab Biological: filgrastim Biological: pegfilgrastim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Lymph Node Positive Breast Cancer |
Estimated Enrollment: | 212 |
Study Start Date: | October 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, multicenter study. Patients are sequentially assigned to 1 of 2 treatment groups.
Treatment in both groups continues in the absence of disease recurrence or unacceptable toxicity.
Patients who require radiotherapy (post-lumpectomy) or who plan radiotherapy at the discretion of the investigator (post-mastectomy) undergo radiotherapy beginning within 6 weeks after the completion of chemotherapy.
Premenopausal patients* with ER- and/or PR-positive disease receive oral tamoxifen once daily for 5 years beginning at the time of radiotherapy or within 6 weeks after the completion of chemotherapy. Postmenopausal patients with ER- and/or PR-positive disease receive an aromatase inhibitor (e.g., anastrozole, letrozole, or exemestane) or tamoxifen followed by an aromatase inhibitor once daily for up to 10 years.
NOTE: *Premenopausal patients may participate in SOFT, TEXT, or PERCHE clinical trials.
After completion of study treatment, patients are followed every 3 months for 6 months and then every 6 months for up to 3 years from study entry.
PROJECTED ACCRUAL: A total of 212 patients (106 for group I and 106 for group II) will be accrued for this study within 1.4-6.7 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Node-positive disease in 1 or more axillary or internal mammary lymph node by histology with hematoxylin and eosin staining
Has undergone prior definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, lumpectomy and axillary dissection or lumpectomy and sentinel node biopsy within the past 29-84 days (group I only)
Surgical margins must be histologically free of invasive tumor AND ductal carcinoma in situ
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
More than 4 weeks since prior major surgery
Other
No concurrent therapeutic anticoagulants
No other concurrent drugs known to inhibit platelet function, including any of the following:
Study Chair: | Kathy Miller, MD | Indiana University Melvin and Bren Simon Cancer Center |
Investigator: | Robin Zon, MD | Michiana Hematology-Oncology, PC - South Bend |
Study Chair: | Edith A. Perez, MD | Mayo Clinic |
Study ID Numbers: | CDR0000434634, ECOG-E2104 |
Study First Received: | July 12, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00119262 History of Changes |
Health Authority: | United States: Federal Government |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer male breast cancer |
Skin Diseases Immunologic Factors Adjuvants, Immunologic Breast Neoplasms Antimitotic Agents Breast Cancer, Male Cyclophosphamide Bevacizumab Angiogenesis Inhibitors Immunosuppressive Agents |
Doxorubicin Anti-Bacterial Agents Breast Neoplasms, Male Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Breast Diseases Skin Diseases Growth Substances |
Mitosis Modulators Breast Neoplasms Antimitotic Agents Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Doxorubicin Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |