National Cancer Institute - NCI Division of Cancer Treatment and ...

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