Breast Cancer :: ARIMIDEX with HERCEPTIN Extended Survival in Breast Cancer

Data was presented today showing that postmenopausal women who received ARIMIDEX (anastrozole) and Herceptin (trastuzumab) in combination had a significant improvement in progression-free survival when treated for advanced breast cancer that was both human epidermal growth factor receptor-2 (HER-2)-positive and hormone receptor-positive.

Data from the TAnDEM randomized clinical trial evaluating ?co-positive? patients was presented today for the first time in North America at the 2006 San Antonio Breast Cancer Symposium (SABCS).

Study participants who received ARIMIDEX and Herceptin in combination demonstrated an extended median progression-free survival of 4.8 months, representing an extension of 2.4 months over patients receiving ARIMIDEX alone. The overall median survival for patients receiving ARIMIDEX with Herceptin was 28.5 months.

?The combination of ARIMIDEX plus Herceptin suggests a significant improvement in progression-free survival for this unique patient population, whose disease can be particularly aggressive,? said Dr. Joseph Purvis, AstraZeneca, Executive Director, Clinical Research, Oncology.

About TAnDEM Results

The multi-center trial began enrollment in 2001 and evaluated 208 postmenopausal women in 22 countries. In women receiving ARIMIDEX plus Herceptin, time to tumor progression (TTP) was doubled (4.8 versus 2.4 months) and median overall survival (OS) prolonged by 4.6 months compared to women receiving ARIMIDEX alone (28.5 versus 23.9 months). Patients in the combination arm had an overall response rate that was higher than those receiving ARIMIDEX alone (20.3 % versus 6.8%).

ARIMIDEX was scheduled at a dose of 1 mg daily until disease progression. Herceptin was administered in 2 mg/kg weekly (after an initial loading dose of 4 mg/kg) until disease progression. While patients who participated in this study continue to be followed for any side effects, overall safety data in both arms of the TAnDEM trial were consistent with the known safety profile of each of the drugs in the advanced breast cancer setting.

About Advanced Breast Cancer

Breast cancer is considered advanced when it has spread from its original site to distant areas of the body. There are two different ways advanced breast cancer can be classified: locally advanced or metastatic. Locally advanced breast cancer indicates that the cancer is large (greater than two inches) or may have spread to other nearby tissue such as skin, underlying muscle, or chest wall, or there is extensive lymph node involvement. Metastatic breast cancer indicates that the cancer has spread from the breast and lymph nodes to other parts of the body such as bone, lung, liver, or brain.

Approximately two-thirds of breast cancer patients are hormone receptor-positive1 and of these, nearly 25 percent have the HER-2 genetic mutation.2 This HER-2 mutation marks the presence of a protein that promotes the growth of cancerous cells, typically resulting in a more aggressive tumor.

Important Information about ARIMIDEX? (anastrozole) Tablets

ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer, and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.

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