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Phase III Study of Adriamycin/Taxotere Versus Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast CancerUnique Dataset IDnci-data-380ClinicalTrial.gov IDNCT00003519
Clinical Trial Title
Phase III Study of Adriamycin/Taxotere Versus Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast Cancer
Trial Summary and Conditions
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.
See data dictionary for more details.
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.
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
This dataset contains the analysis data for the MetaSite BreastTM score analysis (n=600) published in PMID 29138761 with a subset of cases from the parent trial NCT00003519.
Available Downloads: NCT00003519-D1
To gain access to the data and analytic tools click here.
Data Dictionary: NCT00003519-D1-Data-Dictionary.pdf