Combination Chemotherapy in Treating Women With Breast Cancer
|ClinicalTrials.gov Identifier: NCT00003519|
Recruitment Status : Completed
First Posted : August 26, 2004
Last Update Posted : January 28, 2010
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride||Phase 3|
OBJECTIVES: I. Determine whether doxorubicin/docetaxel (DD) will improve disease-free survival and overall survival when compared to doxorubicin/cyclophosphamide (DC) in women with lymph node positive (1-3 positive nodes) or high risk lymph node negative breast cancer. II. Compare the toxicity of DD to DC in this patient population.
OUTLINE: This is a randomized study. Patients are stratified by node status (positive vs negative), menopause status (pre- vs post), estrogen receptor (ER) status/progesterone receptor (PR) status (ER/PR unknown vs ER+/PR+ vs ER+/PR- vs ER-/PR+ vs ER-/PR-). Patients in arm I receive doxorubicin IV plus docetaxel IV over 1 hour every 3 weeks for 4 treatment courses. Patients in arm II receive doxorubicin IV plus cyclophosphamide IV every 3 weeks for 4 treatment courses. All patients who are estrogen receptor or progesterone receptor positive receive oral tamoxifen daily for 5 years following chemotherapy. Some patients may also receive radiotherapy following chemotherapy. Patients are followed every 3 months if patient is less than 2 years from study entry; every 6 months if patient is 2-5 years from study entry; and every 12 months if patient is greater than 5 years from study entry.
PROJECTED ACCRUAL: Approximately 2778 patients will be accrued for this study within 2.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2778 participants|
|Official Title:||Phase III Study of Adriamycin/Taxotere Versus Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast Cancer|
|Study Start Date :||August 1998|
|Primary Completion Date :||January 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003519
Show 134 Study Locations
|Study Chair:||Lori J. Goldstein, MD||Fox Chase Cancer Center|
|Study Chair:||Silvana Martino, DO||Van Nuys Breast Center|
|Study Chair:||Edith A. Perez, MD||Mayo Clinic|
|Study Chair:||Larry Norton, MD||Memorial Sloan Kettering Cancer Center|