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

What is the purpose of this trial?

NSABP B-47, a Phase III, multicenter, open-label, randomized adjuvant therapy trial, will compare the value of adding trastuzumab to chemotherapy relative to chemotherapy without trastuzumab in women with resected node-positive or high-risk node-negative HER2-low invasive breast cancer. For the B-47 trial, HER2-low is defined as either an IHC score of 1+ or an IHC score of 2+ with negative in situ hybridization.

This trial will determine whether the addition of trastuzumab to standard chemotherapy regimens improves invasive disease-free survival relative to chemotherapy alone. Secondary aims include determining whether the addition of trastuzumab to chemotherapy improves disease-free survival, breast cancer-free survival, recurrence-free interval, distant recurrence-free interval, and overall survival relative to chemotherapy alone. Additionally, the toxicities of the regimens will be compared.

Participation Guidelines

Click here for detailed information about who can participate in this trial.

Sponsor:

NSABP

Dates:

October 2012

Last Updated:

Study HIC#:

1208010649

Clinicaltrials.gov ID: Yale0256420