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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Bayer |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00544167 |
Sorafenib is being looked at in a number of solid tumor settings including breast cancer. This trial is designed as a pilot study to assess the safety and tolerability of a novel oral agent in combination with standard chemotherapy in the treatment of early stage node positive or otherwise high-risk breast cancer. If this should prove to be a tolerable regimen for patients, this would provide rationale for further studies in a larger randomized fashion.
Condition | Intervention |
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Breast Cancer |
Drug: Doxorubicin, Cyclophosphamide, Paclitaxel, Sorafenib |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of Adjuvant Doxorubicin and Cyclophosphamide Followed by Paclitaxel Plus Sorafenib in Women With Node Positive or High-Risk Early Stage Breast Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Doxorubicin 60 mg/m2 IV day1 q21 days x 4 cycles Cyclophosphamide 600 mg/m2 IV day 1 q21 days x 4 cycles Paclitaxel and Sorafenib will not start until after the doxorubicin/cyclophosphamide phase has completed.
Paclitaxel may be administered on one of two schedules at physician discretion:
175 mg/m2 IV day 1 q21 days x 4 cycles OR 80 mg/m2 IV weekly x 4 cycles (12 weeks total)
Sorafenib 400 mg po BID to start concurrent with paclitaxel. Sorafenib will then be held during radiation therapy and resume once radiation is completed. Sorafenib will continue for a total of 12 months and in combination with adjuvant hormonal therapy (for those patients who are deemed candidates for such therapy) in the form of tamoxifen or an aromatase inhibitor. Cycle = 21 days
Primary Objectives The primary objective is to assess the safety and tolerability of doxorubicin / cyclophosphamide followed by paclitaxel in combination with sorafenib in patients with early stage node positive or otherwise high-risk breast cancer.
Secondary Objectives The secondary objectives are to assess activity in the form of recurrence-free-interval, distant recurrence-free interval,and overall survival in this pilot study of doxorubicin / cyclophosphamide followed by paclitaxel in combination with sorafenib in patients with early stage node positive or otherwise high-risk breast cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Definitive surgery - either mastectomy with axillary node involvement assessment, or breast conserving surgery with axillary node assessment.
Margins of resected specimen must be free of invasive disease and/or ductal carcinoma in situ (DCIS). The finding of lobular carcinoma in-situ will not be scored as a positive margin.
Exclusion Criteria:
United States, Florida | |
Florida Hospital Cancer Institute | |
Orlando, Florida, United States, 32804 | |
Integrated Community Oncology Network | |
Jacksonville, Florida, United States, 32256 | |
United States, Kentucky | |
Consultants in Blood Disorders and Cancer | |
Louisville, Kentucky, United States, 40207 | |
United States, Michigan | |
Grand Rapids Clinical Oncology Program | |
Grand Rapids, Michigan, United States, 49503 | |
United States, Nebraska | |
Methodist Cancer Center | |
Omaha, Nebraska, United States, 68114 | |
United States, Tennessee | |
Chattanooga Oncology Hematology Associates | |
Chattanooga, Tennessee, United States, 37404 | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37023 | |
United States, Virginia | |
Peninsula Cancer Institute | |
Newport News, Virginia, United States, 23601 |
Study Chair: | Denise Yardley, M.D. | SCRI Oncology Research Consortium |
Responsible Party: | SCRI Oncology Research Consortium ( Denise A. Yardley, M.D. ) |
Study ID Numbers: | SCRI BRE 112 |
Study First Received: | October 15, 2007 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00544167 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Early Stage High Risk Node Positive |
Doxorubicin Cyclophosphamide Paclitaxel Sorafenib |
Skin Diseases Immunologic Factors Adjuvants, Immunologic Breast Neoplasms Antimitotic Agents Cyclophosphamide Protein Kinase Inhibitors Tamoxifen Immunosuppressive Agents Doxorubicin |
Anti-Bacterial Agents Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Aromatase Inhibitors Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Sorafenib Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Protein Kinase Inhibitors Neoplasms by Site Therapeutic Uses Alkylating Agents Breast Diseases Skin Diseases Mitosis Modulators Breast Neoplasms |
Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Doxorubicin Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Sorafenib Antineoplastic Agents, Phytogenic |