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Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey Cancer and Leukemia Group B |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00698217 |
This purpose of this study is to compare the effectiveness of the standard adjuvant chemotherapy Cyclophosphamide and Doxorubicin (CA) with the chemotherapy drug Paclitaxel. The treatments will be compared to each other to effectiveness to treat your type of cancer and how well you tolerated the treatment that you received.
Cyclophosphamide and Doxorubicin (CA) have been approved by the Food and Drug Administration of the United States (FDA) for the treatment of breast cancer. Paclitaxel given after combination chemotherapy has been approved for the adjuvant treatment of breast cancer that has spread to the lymph nodes. Paclitaxel is also approved for the treatment of breast cancer that has grown or that has spread to other parts of the body after previous chemotherapy. The use of paclitaxel as adjuvant treatment for breast cancer that has not spread to the lymph nodes, as used in this study, are considered to be experimental or research.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: doxorubicin Drug: cyclophosphamide Drug: paclitaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III Randomized Study |
Estimated Enrollment: | 4646 |
Study Start Date: | May 2002 |
Estimated Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Active Comparator
Patients receive doxorubicin IV and cyclophosphamide IV on day 1. Treatment repeats every 14 days for 4 courses.
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Drug: doxorubicin
Patients receive doxorubicin IV
Drug: cyclophosphamide
Patients receive cyclophosphamide IV
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II: Active Comparator
(Closed to accrual as of 1/30/2008):Patients receive doxorubicin and cyclophosphamide as in arm I. Treatment repeats every 14 days for 6 courses.
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Drug: doxorubicin
Patients receive doxorubicin IV
Drug: cyclophosphamide
Patients receive cyclophosphamide IV
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III: Active Comparator
Patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 14 days for 4 courses.
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Drug: paclitaxel
Patients receive paclitaxel IV over 1 hour
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IV: Active Comparator
(Closed to accrual as of 1/30/2008): Patients receive paclitaxel as in arm III. Treatment repeats every 14 days for 6 courses.
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Drug: paclitaxel
Patients receive paclitaxel IV over 1 hour
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria for node-negative disease:
Meets 1 of the following criteria for node-positive disease (1-3 positive axillary lymph nodes):
Modified radical mastectomy or lumpectomy within the past 84 days required
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:
No concurrent exogenous hormonal therapy (including oral contraceptives, postmenopausal hormone replacement therapy, or raloxifene) except:
SURGERY:
OTHER:
Contact: Lillian Pliner, MD | 9739726257 | plinerlf@umdnj.edu |
Contact: Yasmeen S. Barber, BA | 9739727789 | barberys@umdnj.edu |
United States, New Jersey | |
University of Medicine and Dentistry of New Jersey | Recruiting |
Newark, New Jersey, United States, 07101-1709 | |
Contact: Yasmeen S Barber, BA 973-972-7789 barberys@umdnj.edu | |
Principal Investigator: Lillian Pliner, MD | |
Sub-Investigator: Margarette Bryan, MD | |
Sub-Investigator: Meera Hameed, MD | |
Sub-Investigator: Dolly Razdan, MD | |
Sub-Investigator: Charles Cathcart, MD |
Study Chair: | Lawrence N. Shulman, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana Farber Cancer Institute ( Lawrence N. Shulman, MD, Study Chair ) |
Study ID Numbers: | 0120070073 |
Study First Received: | June 12, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00698217 History of Changes |
Health Authority: | United States: Institutional Review Board |
Skin Diseases Immunologic Factors Adjuvants, Immunologic Breast Neoplasms Antimitotic Agents Cyclophosphamide Immunosuppressive Agents Doxorubicin |
Anti-Bacterial Agents Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Breast Neoplasms Antimitotic Agents Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Doxorubicin |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |