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First Taxane-Based Non-Anthracycline Containing Chemotherapy in Combination With Herceptin (TCH) for HER2 Positive Early Breast Cancer Patients Obtains Approval From the FDA

(HR=0.58, 95% CI [0.40-0.83], p=0.0024) compared to the AC-T control arm. There was no statistically significant difference in OS between the two experimental arms (TCH and AC-TH).

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).

Study design

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

concurrently with

SOURCE Cancer International Research Group
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