A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

Summary:
The primary objective of this study is to determine whether the addition of trastuzumab to chemotherapy (TC or AC->WP) improves invasive disease-free survival in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.

Trastuzumab alone or in combination with cytotoxic chemotherapy is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein. Trastuzumab has been shown to inhibit the spread of human tumor cells over-expressing the HER2 growth factor receptor. Trastuzumab is indicated, alone or in combination with cytotoxic chemotherapy, for the treatment of patients with HER2-overexpressing operable early breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant), and radiotherapy.

Eligibility and Treatment Plan:
Female
Age 18 or older
Unilateral invasive adenocarcinoma of the breast
Undergone either a total mastectomy or breast-conserving surgery (lumpectomy)

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