A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone… to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer.

Service: Trial Number:
062-12
Principal Investigator: Conducted at:
Long Beach Memorial, Orange Coast Memorial
Currently enrolling additional patients:
Yes

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. Currently, trastuzumab is a standard treatment for patients with breast cancer that is HER2-positive (a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 [HER2], which promotes the growth of cancer cells). However, it has been seen with previous studies that patients with HER2-low breast cancer have similar benefit from the addition of trastuzumab to patients with tumors that are HER2-positive. The purpose of the study is to determine whether adding a targeted therapy, trastuzumab (cancer treatment that specifically targets the tumor cells by blocking the HER2 protein on the surface of cancer cells) to one of two types of standard chemotherapy treatment: Doxorubicin and Cyclophosphamide followed by Paclitaxel (AC followed by WP); or Docetaxel and Cyclophosphamide (TC), without Paclitaxel, for early stage, high-risk HER2-low breast cancer, will improve invasive disease-free survival relative to chemotherapy alone. Subjects will be randomized to receive chemotherapy with trastuzumab therapy (Group 2) or a group to receive chemotherapy without trastuzumab (Group 1). Subgroups will also be studied.

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