At a glance
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Abraxane and Trastuzumab Followed by Dose Dense Doxorubicin and Cyclophosphamide as Neoadjuvant Therapy in Invasive Breast Cancer With Low HER2 Expression (1+ or 2+ by IHC)
In Brief
A Phase 2 clinical trial evaluating nab-paclitaxel, trastuzumab, and 4 other interventions for Breast Cancer. Completed, enrolled 32 participants across 2 sites.
Detailed Summary
The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.
Study Details
Timeline
Interventions
100 MG/M2 IV over 30 minutes once a week for 12 weeks
4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
60 MG/M2 every two weeks for a total of 4 cycles
600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
* All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle. * Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.
* After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy. * All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.