NCI Description

There are 2 datasets associated with this publication: NCT00070564-D1 and NCT00070564-D2. This dataset will allow users to reproduce analysis in determining the optimal dose and schedule of anthracycline and taxane administration as adjuvant therapy for early-stage breast cancer in PMID 25422488.

Clinical Trial Title

Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the disease-free survival of patients with node-positive or high-risk node-negative breast cancer treated with 2 different schedules of adjuvant doxorubicin, cyclophosphamide, and paclitaxel. Compare the overall survival of patients treated with these regimens. Compare the toxic effects of these regimens in these patients. Correlate outcome with putative prognostic markers in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms (arms V and VI) (arms I-IV closed 11/10/10). In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. In all arms patients with HER2/neu-positive tumors also receive trastuzumab (Herceptin?) weekly or every 3 weeks beginning concurrently with paclitaxel OR 3 months after the last dose of paclitaxel and continuing for up to 52 weeks. In all arms, patients with estrogen-receptor or progesterone-receptor positive tumors receive hormonal therapy beginning within 28 days of the completion of adjuvant chemotherapy or radiotherapy (if given). After finishing study treatment patients are followed up every 6 months for 5 years and then once a year for up to 15 years.

Outcome Measures

Primary: Disease-free Survival [ Time Frame: every 6 months (annually for mammograms) for 5 years ] Overall Survival [ Time Frame: Every 6 months for 5 years ] Secondary: Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs [ Time Frame: Toxicity assessment was evaluated every 4 weeks while on protocol therapy. ] Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years ] Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years ] Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years ] Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years ] Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group [ Time Frame: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

• NCT00070564