At a glance
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Phase II Neoadjuvant Chemotherapy Trial in Clinical Stage II/III Her2Neu Positive Breast Cancer With Sequential AC -> Docetaxel With Concurrent Dual EGFR Kinase Blockade by GW572016 (Lapatinib) Followed by 1 Year Adjuvant Trastuzumab
In Brief
A Phase 2 clinical trial evaluating Lapatinib, Doxorubicin, and 6 other interventions for Breast Cancer and Metastatic Breast Cancer. Completed, enrolled 21 participants across 2 sites.
Detailed Summary
This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC) followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to determine whether lapatinib combined with chemotherapy was safe and resulted in an increase in pathologic complete response rates.
Study Details
Timeline
Interventions
1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles)
60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide.
600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin.
100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments.
300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies.
8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel
Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year