Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC TH) with docetaxel, carboplatin and trastuzumab (TCH) in Her2neu positive early breast cancer patients: BCIRG
Results from the BCIRG
006 clinical trial showed that the TCH regimen reduced the risk of disease recurrence by one third (HR=0.
The major new cardiotoxicity finding in BCIRG
006 was that the asymptomatic decline in left ventricular ejection fraction known to be induced by trastuzumab in a substantial portion of patients, is far more persistent than previously reported.
This translational approach has been used in the BCIRG
006 study and the newly-launched BETH clinical trial.
006 randomized 3,222 patients with HER2-positive breast cancer and positive lymph nodes or other high-risk features to one of three treatment arms: a control group given a standard potent anthracycline-based chemotherapy regimen consisting of four cycles of doxorubicin and cyclophosphamide followed by four of docetaxel, the same regimen with the addition of 1 year of adjuvant trastuzumab beginning concurrent with the docetaxel, or a year of trastuzumab starting at the outset of six cycles of docetaxel and carboplatin.
Aventis Pharmaceuticals, the major sponsor of the BCIRG
trials, provides funding and Taxotere free of charge for all patients.
Additionally, women interested in the BCIRG
trial can call 514-748-3940 or email contact@BCIRG
In the BCIRG
006 study, patients with HER2 overexpression and with node-positive or node-negative disease were randomly assigned between three arms: four cycles of AC followed by four cycles of docetaxel (AC-T), AC-T with trastuzumab commenced alongside docetaxel for 1 year (AC-TH) or six cycles of carboplatin/docetaxel with trastuzumab commenced with chemotherapy for 1 year (TCH).
Slamon D, Eiermann W, Robert N, et al: Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (ACT) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (ACTH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2 positive early breast cancer patients: BCIRG
trial will evaluate AC followed by doxetaxel with and without Herceptin, and will also evaluate a non-anthracycline based regimen of docetaxel, carboplatinum and Herceptin.
The GEICAM 9805/Target-0 trial was initiated as a complementary study to BCIRG
001/TAX 316, a study that enrolled women with node-positive early stage breast cancer.
3] NCCTG N9831 (US), NSABP B-31 (US), HERA - HERceptin Adjuvant (international), BCIRG