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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Cancer and Leukemia Group B |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00590785 |
To compare disease-free survival (DFS), overall survival (s), and toxicity of high-isk primary breast cancer patients with negative axillary lymph nodes or with one to three positive nodes treated with adjuvant high-dose chemotherapy with doxorubicin plus cyclophosphamide (AC), versus high-dose sequential chemotherapy with doxorubicin followed by cyclophosphamide (A-->C).
Condition | Intervention | Phase |
---|---|---|
High Risk Breast Cancer Positive Nodes Cyclophosphamide Doxorubicin |
Drug: Doxorubicin Drug: Cyclophosphamide Drug: G-CSF Drug: tamoxifen Drug: ciprofloxacin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394) |
Estimated Enrollment: | 60 |
Study Start Date: | August 1996 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Doxorubicin
High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
Drug: Cyclophosphamide
High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
Drug: G-CSF
High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
Drug: tamoxifen
High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
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2: Experimental |
Drug: Doxorubicin
High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
Drug: Cyclophosphamide
High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
Drug: G-CSF
High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.
Drug: ciprofloxacin
High-dose sequential doxorubicin x 4 given with G-CSF on Days 3 - 12+ and followed by high-dose cyclophosphamide x 3 (A+C) given with G-CSF and ciprofloxacin on Days 3-12, followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamxifen 20 mg daily for 5 years.
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
disease must be considered sufficiently high-risk by the investigator to justify the use of chemotherapy. To be eligible, disease must satisfy one of the following requirements:
This must Include normal WBC (2 4,0001pl). neutrophll count (2 1,50O/pl), platelet count (2 Institutional lower limit of normal), and LVEF (left ventricular ejection fraction by institutional criteria); bilirubin within 1.5 times institutional upper limit of normal; creatinine within 1.5 times institutional upper limit of normal; and no serious disease other than breast cancer.
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Clifford Hudis, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Clifford Hudis MD ) |
Study ID Numbers: | 96-041, INT 0137, CALGB 9394 |
Study First Received: | December 26, 2007 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00590785 History of Changes |
Health Authority: | United States: Food and Drug Administration |
High Risk Breast Cancer Positive Nodes |
Cyclophosphamide Doxorubicin 96-041 |
Estrogen Antagonists Estrogens Antineoplastic Agents, Hormonal Skin Diseases Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Adjuvants, Immunologic Breast Neoplasms Bone Density Conservation Agents Cyclophosphamide Selective Estrogen Receptor Modulators |
Tamoxifen Hormones Immunosuppressive Agents Doxorubicin Estrogen Receptor Modulators Anti-Bacterial Agents Ciprofloxacin Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Cyclophosphamide Selective Estrogen Receptor Modulators Antibiotics, Antineoplastic Estrogen Receptor Modulators Ciprofloxacin Neoplasms by Site Therapeutic Uses |
Alkylating Agents Nucleic Acid Synthesis Inhibitors Breast Diseases Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Breast Neoplasms Enzyme Inhibitors Tamoxifen Immunosuppressive Agents Pharmacologic Actions Doxorubicin Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating |