Breast Cancer
*Note: Validation studies have already been performed on the 21-gene
Oncotype
DX Breast Cancer Assay for node-negative and node-positive, estrogen-receptor-positive
(ER+) breast cancer; for single gene reporting quantitative of ER (estrogen receptor),
PR (progesterone receptor negative) and HER2 (human epidermal growth factor receptor
2) genes, and for patients treated with Tamoxifen or an Aromatase Inhibitor. The
21-gene breast cancer test is currently commercially available. For detailed information
about Oncotype DX, please call: (866) ONCOTYPE or visit www.oncotypedx.com
Oncotype DX 21-Gene Breast Cancer Assay
|
New Targets in Development:
|
Ductal Carcinoma In Situ (DCIS): Development stage
Chemotherapy benefit with specific drugs/drug classes (e.g., taxanes, anthacyclines,
angiogenesis inhibitors, PARP inhibitors): Development stage
|
|
U.S. Incidence of Breast Cancer
|
270,000/Year1
|
|
U.S. Incidence of DCIS
|
45,000/Year2
|
|
Global Incidence of Breast Cancer
|
1.15 Million/Year3
|
About Breast Cancer
Breast cancer is a cancer that forms in the breast tissue, most often in the lobules
(glands where milk is made) or ducts (tubes that carry milk to the nipple). Although
most cases of breast cancer occur in women, it can also occur in men. Among women
(in both the U.S. and worldwide), breast cancer is by far the most common type of
cancer.
About the Oncotype DX Breast Cancer Test
Genomic Health´s Oncotype DX Breast Cancer Assay is a multigene expression
test that physicians currently use to predict the likelihood of chemotherapy
benefit and recurrence risk for patients with early-stage, estrogen receptor positive
(ER+) breast cancer. The test has been shown to predict the magnitude of chemotherapy
benefit for breast cancer patients treated with a variety of different chemotherapy
regimens such as CMF, CAF, and regimens containing, taxane suggesting that the 21-gene
test can predict the benefit, generally, from chemotherapy. Additionally, the Oncotype
DX breast cancer test report also provides quantitative scores for ER, PR and HER2,
which can help inform treatment planning
Ductal Carcinoma In Situ of the Breast (DCIS)
DCIS is an early form of breast cancer that is being diagnosed at an increasing
rate, with an estimated 45,000 U.S. cases reported in 20092. Unlike invasive
breast cancer, the
tumor cells in DCIS are not found outside of the ducts within the breast.
However, women who are diagnosed with DCIS have a small risk of recurrence of DCIS
or of progression to invasive breast cancer.
Potential Oncotype DX Use in DCIS Ttreatment Planning
Current treatment for DCIS includes surgery, followed in many cases by radiation
therapy and/or hormonal therapy. While the benefit of these DCIS treatments has
been established, it is clear that not all patients benefit equally. Genomic Health
completed a pilot study in 2008, confirming that RNA extraction and RT-PCR technology,
the same technology used for the commercially available 21-gene Oncotype
DX test, is viable for DCIS. The study also showed DCIS to exhibit a wide range
of Recurrence Scores®, suggesting that Oncotype DX may be able to
predict the likelihood of breast cancer recurrence for this patient population.
Genomic Health is currently in the process of collecting tissue for large clinical
studies in DCIS. A clinical assay for DCIS could result from validation using the
current 21 genes or, alternatively, on the basis of new additional genes. For additional
information, visit Genomic Health´s Pipeline
page.
Chemotherapy Benefit With Specific Drugs/Drug Classes (e.g., taxanes, anthracyclines,
angiogenesis inhibitors, PARP inhibitors)
Although it has been shown that selection of multi-drug therapy provides benefit
for certain patients with early-stage breast cancer, it is not yet possible to identify
which patients benefit the most from which drug combinations. As the number of treatment
options increases, it has become even more important to understand which patients
would benefit from which drugs. Studies are in progress to develop clinical tests
to guide selection of specific drugs and/or drug classes, such as taxanes, anthracyclines,
angiogenesis inhibitors, and PARP inhibitors.
Learn more about additional Genomic Health products in development:
Contact
Genomic Health for more information about the Oncotype DX breast cancer
test.