Moreover, with the TCH regimen, the risk of congestive heart failure was five-fold lower compared to that observed with AC-TH (0.4% vs 1.9% vs 0.3% in women treated with TCH, AC-TH, and AC-T respectively).
"The BCIRG 006 trial results give us a new option for the treatment of HER2 positive breast cancer. This approach exploits the most recent molecular information regarding the HER2 alteration allowing us to retain the remarkable benefits of Herceptin while leaving behind almost all of the major side effects," said Professor Dennis Slamon, Professor and Chief Hematology-Oncology UCLA Los Angeles and CIRG Chair. "The BCIRG design, while initially received controversially, was based on clean preclinical evidence that led us to test a novel combination of drugs in breast cancer."
About BCIRG 006
The BCIRG 006 was a phase III multicenter study conducted by the CIRG and sponsored by sanofi-aventis (Paris, France) with additional support from Genentech (South San Francisco, USA).
3,222 women with HER2-positive node-positive and high-risk
node-negative operable breast cancer were enrolled and randomly assigned to
one of the following treatments:
- AC-T (n=1,073), the anthracycline-containing control regimen consisting
of doxorubicin (A, 60 mg/m2) plus cyclophosphamide (C, 600 mg/m2) every
three weeks for four cycles followed by Taxotere(R) (T, 100 mg/m2)
every three weeks for four cycles.
- AC-TH (n=1.074), the anthracycline-containing experimental regimen
consisting of AC every three weeks for four cycles followed by
Taxotere(R) (T, 100 mg/m2) every three weeks for four cycles plus
Herceptin(R) (H, 4 mg/kg loading dose followed by 2 mg/kg per week
|SOURCE Cancer International Research Group|
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