TAILORx Press Release

October 25, 2010: Philadelphia, PA: Are some women with breast cancer being over-treated with chemotherapy? Breast cancer experts are completing an important milestone this month in their research to answer this question, as they complete accrual of over 10,000 women with early stage breast cancer to the TAILORx clinical trial. TAILORx or "Trial Assigning IndividuaLized Options for Treatment (Rx)” is a clinical research trial for women with early-stage breast cancer. It is the first breast cancer clinical trial ever conducted which integrates a state-of-the-art gene expression assay into the clinical decision-making process. When the final results become available, this federally funded trial will help identify in which patients adjuvant hormonal therapy alone is sufficient treatment, thus eliminating the empiric use of chemotherapy in tens of thousands of women with early stage breast cancer each year.

“This is a groundbreaking trial” said Robert L. Comis, MD, Chair of the Eastern Cooperative Group (ECOG), which coordinated the study with funding provided by the National Cancer Institute. “In today’s era of personalized medicine, prospective clinical trials like TAILORx are critical to translating what we’ve learned about cancer biology into individualizing therapy, so that we can treat the right patient with the right therapy at the right time. When the results become available within the next five years, they will shed light on who really benefits from chemotherapy.”

The trial included women age 18-75 with estrogen-receptor positive, lymph node negative stage I or II breast cancer, all of whom met standard clinical guidelines for receiving chemotherapy in order to reduce the risk of cancer recurrence after surgery. All patients had an Oncotype DX^® Recurrence Score^® test performed on their tumor sample, which is a gene expression assay test available from Genomic Health, Inc. The test measures the activity level of a panel of genes within the tumor sample, and the result correlates with the likelihood of having breast cancer recurrence. Tumors with a low Recurrence Score are likely to be cured with surgery and hormonal therapy alone. Tumors with a high Recurrence Score have a high recurrence rate with hormonal therapy and require chemotherapy to reduce the post-surgery recurrence risk. Women in the study will be followed for up to 20 years. “The Recurrence Score test results provided a clear treatment path for about one-third of women who participated in the trial because their score was either low or high.” said Joseph Sparano, MD, the principal investigator of the trial. “The remaining two-thirds of women with a mid-range score tumor were the focus of this trial because we have strong reason to believe that they don’t benefit from chemotherapy. We needed a large-scale clinical trial to prove whether chemotherapy is benefiting this group, or not.”

“This is a very important trial, no matter what the results turn out to be”, said Mary Lou Smith, a breast cancer survivor who serves as the co-chair of the ECOG Patient Representative Committee. “The research team asked what concerns patients might have from the very beginning, and sought advice on how to design a trial that would be acceptable to patients. I think that effort proved to be critical to its success.” The trial received funding from the Breast Cancer Research Foundation, which provides critical grants for innovative clinical and genetic research. It was endorsed by the National Breast Cancer Coalition, an advocacy group which supports increased funding for breast cancer care and research. In 2008, the Coalition of Cancer Cooperative Groups and its Scientific Leadership Council in Breast Cancer deemed TAILORx a High Priority Trial and distinguished it as such in TrialCheck^®, its Internet-based protocol navigation and patient-matching system for all federally (U.S.) registered cancer clinical research studies.

TAILORx was coordinated by the NCI-sponsored Eastern Cooperative Oncology Group, and performed by ECOG, Southwest Oncology Group, Cancer and Leukemia Group B, North Central Cancer Treatment Group, National Surgical Adjuvant Breast and Bowel Project, National Cancer Institute of Canada, Radiation Therapy Oncology Group, and the American College of Surgery Oncology Group. About 9,000 patients were accrued in the United States, whereas the remainders were accrued in Ireland, Peru, Canada, and Australia. The trial included over 900 centers on four continents. “This trial received not only an unprecedented degree of collaboration by the cancer research community, but also unwavering support from our patients,” said Dr. Comis.

TAILORx also seeks to determine if the Oncotype DX assay will be helpful in future treatment planning for this group of women. The initial studies that established the importance of the Oncotype DX test resulted from a research collaboration between the NSABP (noted above) and Genomic Health, Inc. The results of the NSABP B-14 trial established the prognostic value of the assay while the NSABP B-20 trial established the predictive value of the assay in determining the magnitude of chemotherapy benefit. “These trials, along with TAILORx are examples of how federally funded cancer cooperative groups can successfully partner with industry for the benefit of patients” said Steve Shak, MD, Chief Medical Officer of Genomic Health. “We are proud that Oncotype DX testing is playing such a critical role in the TAILORx trial.”

Most of the 10,000 women participating in the trial also agreed to have their tumor and blood specimens banked for evaluating other cancer tests in future. “The banked specimens from TAILORx will be a valuable resource for developing even better tests in the future”, said Dr. Sparano.

The Coalition of Cancer Cooperative Groups is a non-profit service organization working to improve physician and patient access to cancer clinical trials through education, outreach, advocacy and research. Its Board Members are the chairs of the United States’ Cancer Cooperative Groups, the publicly-funded cancer research networks sponsored by the National Cancer Institute. Its web site is www.CancerTrialsHelp.org.

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Breast cancer is the most frequently diagnosed cancer in women, with an estimated 207,090 new cases of invasive breast cancer expected in the United States in 2010 (American Cancer Society). About one-half of these women will have estrogen receptor positive, lymph node negative breast cancer. For 80-85 percent of those women, the current standard treatment practice is surgical excision of the tumor, followed by radiation and hormonal therapy. Chemotherapy is also currently recommended for most women (Also see National Cancer Institute: http://www.cancer.gov/newscenter/pressreleases/TAILORxRelease.)


	Media Contact: Diane D. Colaizzi 215.789.3612 dcolaizzi@CancerTrialsHelp.org
Historic TAILORx Breast Cancer Clinical Trial Reaches Patient Accrual Goal
October 25, 2010: Philadelphia, PA: Are some women with breast cancer being over-treated with chemotherapy? Breast cancer experts are completing an important milestone this month in their research to answer this question, as they complete accrual of over 10,000 women with early stage breast cancer to the TAILORx clinical trial. TAILORx or "Trial Assigning IndividuaLized Options for Treatment (Rx)” is a clinical research trial for women with early-stage breast cancer. It is the first breast cancer clinical trial ever conducted which integrates a state-of-the-art gene expression assay into the clinical decision-making process. When the final results become available, this federally funded trial will help identify in which patients adjuvant hormonal therapy alone is sufficient treatment, thus eliminating the empiric use of chemotherapy in tens of thousands of women with early stage breast cancer each year. “This is a groundbreaking trial” said Robert L. Comis, MD, Chair of the Eastern Cooperative Group (ECOG), which coordinated the study with funding provided by the National Cancer Institute. “In today’s era of personalized medicine, prospective clinical trials like TAILORx are critical to translating what we’ve learned about cancer biology into individualizing therapy, so that we can treat the right patient with the right therapy at the right time. When the results become available within the next five years, they will shed light on who really benefits from chemotherapy.” The trial included women age 18-75 with estrogen-receptor positive, lymph node negative stage I or II breast cancer, all of whom met standard clinical guidelines for receiving chemotherapy in order to reduce the risk of cancer recurrence after surgery. All patients had an Oncotype DX^® Recurrence Score^® test performed on their tumor sample, which is a gene expression assay test available from Genomic Health, Inc. The test measures the activity level of a panel of genes within the tumor sample, and the result correlates with the likelihood of having breast cancer recurrence. Tumors with a low Recurrence Score are likely to be cured with surgery and hormonal therapy alone. Tumors with a high Recurrence Score have a high recurrence rate with hormonal therapy and require chemotherapy to reduce the post-surgery recurrence risk. Women in the study will be followed for up to 20 years. “The Recurrence Score test results provided a clear treatment path for about one-third of women who participated in the trial because their score was either low or high.” said Joseph Sparano, MD, the principal investigator of the trial. “The remaining two-thirds of women with a mid-range score tumor were the focus of this trial because we have strong reason to believe that they don’t benefit from chemotherapy. We needed a large-scale clinical trial to prove whether chemotherapy is benefiting this group, or not.” “This is a very important trial, no matter what the results turn out to be”, said Mary Lou Smith, a breast cancer survivor who serves as the co-chair of the ECOG Patient Representative Committee. “The research team asked what concerns patients might have from the very beginning, and sought advice on how to design a trial that would be acceptable to patients. I think that effort proved to be critical to its success.” The trial received funding from the Breast Cancer Research Foundation, which provides critical grants for innovative clinical and genetic research. It was endorsed by the National Breast Cancer Coalition, an advocacy group which supports increased funding for breast cancer care and research. In 2008, the Coalition of Cancer Cooperative Groups and its Scientific Leadership Council in Breast Cancer deemed TAILORx a High Priority Trial and distinguished it as such in TrialCheck^®, its Internet-based protocol navigation and patient-matching system for all federally (U.S.) registered cancer clinical research studies. TAILORx was coordinated by the NCI-sponsored Eastern Cooperative Oncology Group, and performed by ECOG, Southwest Oncology Group, Cancer and Leukemia Group B, North Central Cancer Treatment Group, National Surgical Adjuvant Breast and Bowel Project, National Cancer Institute of Canada, Radiation Therapy Oncology Group, and the American College of Surgery Oncology Group. About 9,000 patients were accrued in the United States, whereas the remainders were accrued in Ireland, Peru, Canada, and Australia. The trial included over 900 centers on four continents. “This trial received not only an unprecedented degree of collaboration by the cancer research community, but also unwavering support from our patients,” said Dr. Comis. TAILORx also seeks to determine if the Oncotype DX assay will be helpful in future treatment planning for this group of women. The initial studies that established the importance of the Oncotype DX test resulted from a research collaboration between the NSABP (noted above) and Genomic Health, Inc. The results of the NSABP B-14 trial established the prognostic value of the assay while the NSABP B-20 trial established the predictive value of the assay in determining the magnitude of chemotherapy benefit. “These trials, along with TAILORx are examples of how federally funded cancer cooperative groups can successfully partner with industry for the benefit of patients” said Steve Shak, MD, Chief Medical Officer of Genomic Health. “We are proud that Oncotype DX testing is playing such a critical role in the TAILORx trial.” Most of the 10,000 women participating in the trial also agreed to have their tumor and blood specimens banked for evaluating other cancer tests in future. “The banked specimens from TAILORx will be a valuable resource for developing even better tests in the future”, said Dr. Sparano. The Coalition of Cancer Cooperative Groups is a non-profit service organization working to improve physician and patient access to cancer clinical trials through education, outreach, advocacy and research. Its Board Members are the chairs of the United States’ Cancer Cooperative Groups, the publicly-funded cancer research networks sponsored by the National Cancer Institute. Its web site is www.CancerTrialsHelp.org. ### Breast cancer is the most frequently diagnosed cancer in women, with an estimated 207,090 new cases of invasive breast cancer expected in the United States in 2010 (American Cancer Society). About one-half of these women will have estrogen receptor positive, lymph node negative breast cancer. For 80-85 percent of those women, the current standard treatment practice is surgical excision of the tumor, followed by radiation and hormonal therapy. Chemotherapy is also currently recommended for most women (Also see National Cancer Institute: http://www.cancer.gov/newscenter/pressreleases/TAILORxRelease.)