|Personalized Treatment Trial for Breast Cancer
The Trial Assigning IndividuaLized Options for Treatment (Rx),
or TAILORx, was launched today to examine whether genes that are
frequently associated with risk of recurrence for women with early-stage
breast cancer can be used to assign patients to the most appropriate
and effective treatment. TAILORx is sponsored by the National Cancer
Institute (NCI), part of the National Institutes of Health (NIH),
and is coordinated by the Eastern Cooperative Oncology Group (ECOG).
All of the NCI-sponsored clinical trials groups* that
perform breast cancer research studies have collaborated in the
trial’s development and are participating in this study.
“This trial is important because it is one of the first to examine
a methodology for personalizing cancer treatment,” said NIH Director
Elias A, Zerhouni, M.D.
The majority of women with early-stage breast cancer are advised
to receive chemotherapy in addition to radiation and hormonal therapy,
yet research has not demonstrated that chemotherapy benefits all
of them equally. TAILORx seeks to incorporate a molecular profiling
test (a technique that examines many genes simultaneously) into
clinical decision making, and thus spare women unnecessary treatment
if chemotherapy is not likely to be of substantial benefit to them.
The study will enroll over 10,000 women at 900 sites in the United
States and Canada. Women recently diagnosed with estrogen receptor
and/or progesterone receptor positive, Her2/neu negative breast
cancer, which has not yet spread to the lymph nodes, are eligible
for the study. Overexpression of the Her2/neu gene carries poorer
prognosis for patients.
TAILORx will determine the most effective current approach to
cancer treatment, with the fewest side effects, for women with
early-stage breast cancer by using Oncotype DX™, a validated diagnostic
test developed by Genomic Health, Inc., Redwood City, Calif., in
collaboration with the National Surgical Adjuvant Breast and Bowel
Project (NSABP), a network of cancer research professionals. TAILORx
is the first 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.
Research appearing online today in the Journal of Clinical Oncology**
provides strong evidence for the value of using Oncotype DX™ to
help women with this form of breast cancer determine whether they
will benefit by adding chemotherapy to hormonal therapy. This study,
as well as several other similar studies in recent years, provided
the basis for the launch of TAILORx.
Breast cancer is the most frequently diagnosed cancer in women,
with an estimated 212,920 new cases of invasive breast cancer expected
in the United States in 2006. Over one-half of these women will
have estrogen receptor positive, lymph node negative breast cancer.
For 80 percent to 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 recommended
for most women, but the proportion of women who actually benefit
substantially from chemotherapy is fairly small.
“A large number of these women are receiving toxic chemotherapy
unnecessarily, and we need a means of identifying them,” said Jo
Anne Zujeweski, M.D., senior investigator in the Clinical Investigation
Branch of NCI’s Cancer Therapy Evaluation Program. “TAILORx could
help change the way we treat breast cancer and improve the quality
of patients’ lives, helping to better identify women who are likely
to benefit from chemotherapy from those who are not.”
Oncotype DX™ measures the levels of expression of 21 genes (whether
they are transcribed into messenger RNA) in breast tumors. This
assessment can more precisely estimate a person’s risk of recurrence
than standard characteristics, such as tumor size and grade. Based
on the Oncotype DX™ gene expression analysis, a recurrence score
from 0 to 100 is generated; the higher the score, the greater a
woman’s chance of having a recurrence if treated with hormonal
Women will be studied for 10 years, with an additional follow-up
of up to 20 years after initial therapies. Based on their recurrence
score, women will be assigned to three different treatment groups
in the TAILORx study:
- Women with a recurrence score higher than 25 will receive chemotherapy
plus hormonal therapy (the standard of care)
- Women with a recurrence score lower than 11 will receive hormonal
- Women with a recurrence score of 11 to 25 will be randomly
assigned to receive adjuvant hormonal therapy, with or without
TAILORx is designed primarily to evaluate the effect of chemotherapy
on those with a recurrence score of 11 to 25. Women in this last
group will comprise 4,390 women, or about 44 percent of the study
population. Because the degree of benefit of chemotherapy for women
with recurrence scores between 11 and 25 is uncertain, TAILORx
seeks to determine if the Oncotype DX™ test will be helpful in
future treatment planning for this group.
Hormonal therapies in the trial are assigned based on menopausal
status and include tamoxifen and the aromatase inhibitors anastrozole,
letrozole and exemestane. Women on the chemotherapy arm of the
trial will receive one of several standard combination chemotherapy
regimens considered to be the best available standard care today.
It will also be possible for women participating in TAILORx to
participate in other NCI-sponsored clinical trials, provided the
therapy prescribed in the clinical trial is consistent with their
assigned therapy in TAILORx.
Additional goals of this clinical study are to create a tissue
and specimen repository for patients enrolled in the trial and
to collect follow-up information regarding the health status of
those who participate in the study. Tissue collected in this study
will be stored for use in future studies to learn more about breast
cancer and to evaluate, and potentially refine, diagnostic tests
for treatment decisions to an even greater degree than in TAILORx.
“With TAILORx, we are taking a big step toward personalized medicine.
By using cutting- edge diagnostic tests, we’ll be able to customize
an individual’s cancer treatment,” said Joseph Sparano, M.D., Montefiore
Medical Center, Bronx, NY, and Eastern Cooperative Oncology Group
Women in the study will have a physical exam performed by their
doctor every three to six months for the first five years, then
once a year after that for up to 20 years. An annual mammogram
will check for signs of recurrence.
For eligibility and registration information regarding TAILORx,
go to http://www.ctsu.org/ and enter “TAILORx” in the search box.
To view a Q&A on TAILORx, go to http://www.cancer.gov/newscenter/pressreleases/TAILORxQandA.
For a complete set of links and other information related to TAILORx,
go to http://www.cancer.gov/clinicaltrials/digestpage/TAILORx.
For more information about the NCI-sponsored clinical trials groups,
please visit their Web sites:
For more information about cancer, please visit the NCI Web site
at http://www.cancer.gov, or call NCI’s Cancer Information Service
at 1-800-4-CANCER (1-800-422-6237).
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.