|
|
Related Pages |
|
|
|
Search for Clinical Trials
NCI's PDQ® registry of cancer clinical trials.
The TAILORx Breast Cancer Trial
A collection of material about the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, which will examine whether a molecular test can assign women with early-stage breast cancer to the most appropriate and effective treatment.
Breast Cancer Home Page
NCI's gateway for information about breast cancer.
|
|
|
|
|
|
Tailored Treatment for Breast Cancer
Untitled Document
Name of the Trial
Phase III Randomized Study of Adjuvant Combination Chemotherapy and Hormonal
Therapy Versus Adjuvant Hormonal Therapy Alone in Women With Previously Resected
Axillary Node-Negative Breast Cancer With Various Levels of Risk for Recurrence
(TAILORx Trial) (ECOG-PACCT-1). See the protocol
summary.
Principal Investigator
Dr. Joseph A. Sparano, Study Chair, Eastern Cooperative Oncology Group.
Why This Trial Is Important
Adding chemotherapy to hormone therapy in the adjuvant (after surgery) treatment
of women with breast cancer has been shown to reduce the risk of breast cancer
recurrence. However, the additional benefit provided by chemotherapy is small
for women whose lymph nodes are free of disease and whose tumors are positive
for the estrogen hormone receptor. Because chemotherapy can cause serious side
effects, doctors want to find ways to identify patients who will benefit from
chemotherapy and those who may be able to avoid it because of little added benefit.
In this trial, doctors will use a test called the Oncotype DX Breast Cancer
Assay, which measures the activity of a set of genes in breast tumor tissue.
Previous research has shown that a low score in this assay identifies women
who will benefit little from chemotherapy, whereas those with a high score benefit
substantially. More information is needed about women with scores in the middle
range.
Patients will be assigned to one of three major groups. Those with Oncotype
DX scores ≤10 will be treated with adjuvant hormone therapy only.
Women with scores of 11 to 25 will be randomly assigned to adjuvant hormone
therapy alone or adjuvant combination chemotherapy and hormone therapy. Women
with scores ≥26 will be treated with adjuvant combination chemotherapy
and hormone therapy.
Who Can Join This Trial
Researchers will enroll 10,046 women aged 18 to 75 with ER- and/or PR-positive
breast cancer that has not spread to the lymph nodes and can be surgically removed.
See the list
of eligibility criteria.
Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See
the list
of study contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237) for more information. The toll-free call is confidential.
Back to Top |