Are Anthracyclines Necessary in HER2-Positive Breast Cancer?

Are Anthracyclines Necessary in HER2-Positive Breast Cancer?

........The Breast Cancer International Research Group (BCIRG) 006 study established the benefit of trastuzumab (Herceptin) in patients with HER2-positive early-stage breast cancer, and compared how the targeted agent performed in combination with an anthracycline-containing regimen (doxorubicin [Adriamycin], cyclophosphamide, and docetaxel) and with a nonanthracycline regimen (docetaxel and carboplatin).......




BCIRG 006 Study


Study Design



A total of 3,222 women with early-stage HER2-positive breast cancer (including both 
lymph node-positive and node-negative patients) were enrolled into the trial and 
randomly assigned to one of three arms:   


Arm A: doxorubicin and cyclophosphamide (q3w x 4), followed by docetaxel (q3w x 4) 
(AC Æ T) 


Arm B: doxorubicin and cyclophosphamide (q3w x 4), followed by docetaxel (q3w x 4) 
plus Herceptin (qw x 12), followed by Herceptin (q3w x 13) (AC Æ TH) 


Arm C: docetaxel (q3w x 6) plus carboplatin (AUC 6) plus Herceptin (qw x 18), followed 
by Herceptin (q3w x 11) (TCH) 


A pre-planned second interim analysis occurred after 450 events.  The aim of this 
analysis was to detect a significant difference in disease-free survival (the primary 
endpoint of the trial) between the arms.  The secondary endpoints included overall 
survival and safety.