National Cancer Institute - NCI Division of Cancer Treatment and ...
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Trial Assigning Individualized Options for Treatment Contact: Sheila E. Taube, Ph.D. 301-496-8639, st29f@nih.gov Breast cancer stamp sales by the U.S. Postal Service are playing a critical role in making a new, groundbreaking treatment trial possible by providing a portion of the funding for TAILORx. Without this support, the trial would not have been funded. TAILORx, the first trial launched by PACCT, will pioneer the integration of molecular diagnostics into clinical decision-making for breast cancer. The trial will test whether a set of expressed genes that have been shown to be associated with risk of recurrence in women with node-negative, hormone-receptor– positive breast cancer can be used to assign patients to the most appropriate and effective treatment. The signature to be tested is the 21-gene Oncotype DX® panel developed by Genomic Health in collaboration with the NCI cooperative group, National Surgical Adjuvant Breast and Bowel Project (NSABP). Details of the Oncotype DX® test were reported in the articles listed below. The trial is being carried out as a collaboration of CDP, the Cancer Therapy Evaluation Program (CTEP), and all of the NCI clinical cooperative groups that perform breast cancer studies. Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson D, Park T, Hiller W, Fisher ER, Wickerham DL, Bryant J, Wolmark N. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004:351;2817–26. Paik S, Shak S, Tang G, Kim C, Joo H, Baker J, Cronin M, Watson D, Bryant J, Costantino J, Wolmark N. Expression of the 21 genes in the recurrence score assay and prediction of clinical benefit from tamoxifen in NSABP study B-14 and chemotherapy in NSABP study B-20. Presented at: 27th Annual San Antonio Breast Cancer Symposium. December 8–11, 2004. San Antonio, TX. Abstract #24. TAILORx Schema Secondary Study Group Recurrence Score < 11 ~29% of Population ARM A Hormonal Therapy Alone ARM B Hormonal Therapy Alone Preregister ONCOTYPE DX® ASSAY REGISTER Specimen Banking Primary Study Group Recurrence Score 11–25 ~44% of Population RANDOMIZE Secondary Study Group Recurrence Score > 25 ~27% of Population ARM D Chemotherapy Plus Hormonal Therapy ARM C Chemotherapy Plus Hormonal Therapy C A N C E R D I A G N O S I S P R O G R A M ■ 31
Strategic Partnering to Evaluate Cancer Signatures Contacts: James W. Jacobson, Ph.D. 301-402-4185, jacobsoj@mail.nih.gov Tracy Lively, Ph.D. 301-496-1591, livelyt@mail.nih.gov The Strategic Partnering to Evaluate Cancer Signatures (SPECS) program consists of six grants that support multi-institutional, multidisciplinary 32 32 ■ P R O G R A M A C C O M P L I S H M E N T S 2 0 0 6 ■ ■ ■ The Strategic Partnering to Evaluate Cancer Signatures program supports research that bridges the gap between the discovery of molecular signatures and their integration into clinical practice. research teams. The SPECS program leverages NCI’s investment in cancer clinical trials, cancer centers, NCI intramural programs, and the Specialized Programs of Research Excellence (SPORE) program. The projects include collaborations with biotechnology companies, community hospitals, national laboratories, and academic institutions in the United States, Canada, and Europe. The SPECS initiative supports six large collaborative research groups that are exploring how information derived from comprehensive molecular analyses can be used to impact the care of cancer patients and ultimately improve outcomes. SPECS supports research that bridges the gap between the discovery of molecular signatures and their integration into clinical practice. Investigators are refining and confirming both genomic and proteomic signatures that have already been shown to address clinical needs or questions. They are defining the critical components of the signatures and developing robust assays for measuring those components in the clinical setting. They will confirm that the modified signatures provide reproducible, reliable information that can potentially inform clinical decision-making. It is anticipated that the signatures developed in SPECS will lead to assays that are ready for validation in prospective clinical trials.
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Trial Assigning Individualized<br />
Options for <strong>Treatment</strong><br />
Contact:<br />
Sheila E. Taube, Ph.D.<br />
301-496-8639, st29f@nih.gov<br />
Breast cancer stamp sales by the U.S.<br />
Postal Service are playing a critical role<br />
in making a new, groundbreaking treatment<br />
trial possible by providing a portion<br />
<strong>of</strong> the funding for TAILORx. Without this<br />
support, the trial would not have been<br />
funded. TAILORx, the first trial launched<br />
by PACCT, will pioneer the integration<br />
<strong>of</strong> molecular diagnostics into clinical<br />
decision-making for breast cancer. The trial<br />
will test whether a set <strong>of</strong> expressed genes<br />
that have been shown to be associated<br />
with risk <strong>of</strong> recurrence in women with<br />
node-negative, hormone-receptor–<br />
positive breast cancer can be used to<br />
assign patients to the most appropriate<br />
<strong>and</strong> effective treatment. The signature to<br />
be tested is the 21-gene Oncotype DX®<br />
panel developed by Genomic Health in<br />
collaboration with the <strong>NCI</strong> cooperative<br />
group, <strong>National</strong> Surgical Adjuvant Breast<br />
<strong>and</strong> Bowel Project (NSABP). Details <strong>of</strong> the<br />
Oncotype DX® test were reported in the<br />
articles listed below.<br />
The trial is being carried out as a collaboration<br />
<strong>of</strong> CDP, the <strong>Cancer</strong> Therapy Evaluation<br />
Program (CTEP), <strong>and</strong> all <strong>of</strong> the <strong>NCI</strong> clinical<br />
cooperative groups that perform breast<br />
cancer studies.<br />
Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M,<br />
Baehner FL, Walker MG, Watson D, Park T, Hiller<br />
W, Fisher ER, Wickerham DL, Bryant J, Wolmark<br />
N. A multigene assay to predict recurrence<br />
<strong>of</strong> tamoxifen-treated, node-negative breast<br />
cancer. N Engl J Med 2004:351;2817–26.<br />
Paik S, Shak S, Tang G, Kim C, Joo H, Baker J,<br />
Cronin M, Watson D, Bryant J, Costantino J,<br />
Wolmark N. Expression <strong>of</strong> the 21 genes in the<br />
recurrence score assay <strong>and</strong> prediction <strong>of</strong> clinical<br />
benefit from tamoxifen in NSABP study B-14 <strong>and</strong><br />
chemotherapy in NSABP study B-20. Presented<br />
at: 27th Annual San Antonio Breast <strong>Cancer</strong><br />
Symposium. December 8–11, 2004. San Antonio,<br />
TX. Abstract #24.<br />
TAILORx Schema<br />
Secondary Study<br />
Group<br />
Recurrence Score < 11<br />
~29% <strong>of</strong> Population<br />
ARM A<br />
Hormonal Therapy<br />
Alone<br />
ARM B<br />
Hormonal Therapy<br />
Alone<br />
Preregister<br />
ONCOTYPE DX® ASSAY<br />
REGISTER<br />
Specimen Banking<br />
Primary Study<br />
Group<br />
Recurrence Score 11–25<br />
~44% <strong>of</strong> Population<br />
RANDOMIZE<br />
Secondary Study<br />
Group<br />
Recurrence Score > 25<br />
~27% <strong>of</strong> Population<br />
ARM D<br />
Chemotherapy Plus<br />
Hormonal Therapy<br />
ARM C<br />
Chemotherapy Plus<br />
Hormonal Therapy<br />
C A N C E R D I A G N O S I S P R O G R A M ■ 31
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