At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial Comparing the Safety and Efficacy of Adriamycin and Cyclophosphamide Followed by Taxol (AC-T) to That of Adriamycin and Cyclophosphamide Followed by Taxol Plus Herceptin (AC-T+H) in Node-Positive Breast Cancer Patients Who Have Tumors That Overexpress HER2
In Brief
A Phase 3 clinical trial evaluating herceptin, adriamycin, and 2 other interventions for Breast Cancer. Completed, enrolled 2,130 participants across 149 sites in 2 countries.
Detailed Summary
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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus trastuzumab is more effective than combination chemotherapy alone for treating breast cancer. PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy together with trastuzumab works compared to combination chemotherapy alone in treating women with node-positive stage II or stage IIIA breast cancer that overexpresses HER2.
Study Details
Timeline
Interventions
4 mg/kg loading dose then 2 mg/kg weekly for 1 year.
60 mg/m2 IV push every 21 days for 4 cycles.
600 mg/m2 IV every 21 days for 4 cycles
175 mg/m2 IV every 21 days for 4 cycles