Breast Cancer Clinical Trial
Official title:
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)
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.
Neoadjuvant (primary) chemotherapy refers to chemotherapy given before surgery. Neoadjuvant
chemotherapy has a number of potential advantages including increasing the chances for breast
preservation at the time of surgery as well as it may improve the local control of the
cancer. Several national breast cancer studies have shown that neoadjuvant chemotherapy was
equal to chemotherapy given following surgery.
A standard treatment for stage II or Stage III invasive breast cancer with low HER2
expression is combination chemotherapyAdriamycin, Cytoxan,followed by a Taxane: given either
before or after surgery), followed by surgery +/- radiation therapy.
The main purpose of chemotherapy however is to reduce the risk of recurrence of cancer and
also make surgery more successful. HER2 is a receptor located on the surface of some cells.
This receptor plays a role in regulating the growth of the cell, in addition to the growth of
tumors. High levels of the HER2 receptor may predict those women who benefit from treatment
with agents such as Herceptin that target HER2. Herceptin (Trastuzumab) is a drug that is
effective both alone and in combination with standard chemotherapy. There is some data to
suggest that patients whose tumors have low expression of the HER2 protein and are normal by
FISH may also receive benefit from Herceptin.
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