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the Curie Institute; Vall d’Hebron Institute of Technology; and Lund University.
The partners plan to harmonize their methods to make comparisons between fi nd-
ings from each organization, and have started a project database that will be made
available to the public. The partners also are working in collaboration with the
European Bioinformatics Institute through shared participation in the
EUROCANPLATFORM, which is also funded from the EU and will create a
resource for use by the European scientifi c community.
TAILORx (Trial Assigning Individualized Options for Treatment)
Hormone therapy alone is usually given to women at low risk for recurrence of
breast cancer and chemotherapy followed by hormonal therapy to women at a high
risk for recurrence but there is uncertainty about the best way to handle cases that
fall between low and high risk. There is need for a method of tailoring follow-up
treatment that addresses the specifi c characteristics of a patient’s tumor to enable an
accurate prediction of what medical treatments will be most effective for long-term
alleviation of the disease.
The TAILORx study is designed to examine whether women with early-stage
lymph node-negative breast cancer can be assigned to individualized treatment
plans based on certain genes that may predict whether their cancer will recur. It is
sponsored by the NCI and will be conducted by all of the NCI-sponsored clinical
trials groups that perform breast cancer research studies. TAILORx seeks to identify
women who would not benefi t from chemotherapy in order to spare them unneces-
sary treatment. The study is enrolling >10,000 women from 900 sites in the US and
Canada. Women recently diagnosed with ER positive, Her2/neu-negative breast
cancer, which has not yet spread to the lymph nodes, are eligible for the study.
Using Oncotype DX™ (panel of 21 genes with known links to breast cancer), a
modern diagnostic test developed by Genomic Health Inc in collaboration with the
National Surgical Adjuvant Breast and Bowel Project, a network of cancer research
professionals, TAILORx will determine the most effective cancer treatment, with
the fewest side effects, for women with early-stage breast cancer. TAILORx is the
fi rst trial to be launched as part of a new NCI program − the Program for the
Assessment of Clinical Cancer Tests (PACCT) − which seeks to individualize cancer
treatment by using, evaluating and improving the latest diagnostic tests.
One TAILORx phase III clinical trial at uses genetic tests to obtain an individual-
ized and quantitative analysis of how likely a specifi c patient’s breast cancer is to
recur. When a patient enrolls in the trial, a tumor tissue sample is sent to a central
processing laboratory for Oncotype DX™ analysis. Using a statistical risk predic-
tion model, a score is calculated that represents the specifi c patient’s risk for breast
cancer recurrence. The score is determined from the gene expression results using a
range of zero to 100. Scores between 11 and 25 are considered to be in the interme-
diate or unclear risk category this trial focuses on. The information gathered from
the genetic breast cancer test could give physicians a better understanding of the
specifi c characteristics of their patients’ breast tumors, which is critical in planning
accurate treatment plans and follow-up.
10 Personalized Therapy of Cancer