TAILORx Trial Seeks Targeted Treatments for ER+, Node Negative Breast Cancers

By Janine E. Guglielmino, LBBC Staff

Using the Oncotype DX test, researchers hope to find out which early-stage, hormone-sensitive breast cancers can be treated with hormonal therapy alone versus chemotherapy with hormonal therapy

Trial Starts: 3/24/2006

Sponsored By: National Cancer Institute

Learn more about the TAILORx trial.

A new clinical trial from the National Cancer Institute will compare the effectiveness of hormonal therapy alone versus hormonal therapy and combination chemotherapy for women with hormone-positive, early-stage breast cancer who are at risk for recurrence.

The trial, called Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer or TAILORx, could have important treatment implications for women whose breast cancers grow in the presence of estrogen or progesterone.

Why Is This Trial Important?

Breast cancer comes in many forms. To determine the best course of treatment, doctors run a variety of pathology and genetic tests on tissue taken from a cancer to learn more about the nature of that particular cancer. For example, some tests show whether the cancer grows in the presence of estrogen and/or progesterone. Other tests show how fast the tumor cells are dividing or growing. The doctor then uses that information to create a tailored treatment plan for that specific cancer.

Today, the "gold standard," or proven, treatment for most women whose cancers grow in the presence of estrogen but have not spread to the lymph nodes is combination chemotherapy and hormonal therapy. The treatments fight the cancer with a one-two punch: the chemotherapy works by killing rapidly dividing cells, while the hormonal therapy works by targeting the hormones that help the cancer grow.

As researchers develop new and more effective hormonal therapies, they want to learn which women with ER+, node-negative breast cancers need both chemotherapy and hormonal therapy to effectively treat their cancer. They believe that by looking at the genetic make-up of the cancers, they may be able to tell which cancers would benefit most from both treatments, and which may benefit from only one or the other.

The TAILORx trial is the first to address this important question. By determining which ER+, node-negative breast cancers may not derive added benefit from the addition of chemotherapy to hormonal therapy, some women may be able to avoid the toxic side effects of this treatment while getting more targeted, effective treatments against their disease.

What Is the Structure of the TAILORx Trial?

TAILORx is a Phase III clinical trial, meaning it compares the effectiveness of a standard treatment (combination chemotherapy plus hormonal therapy) to a new treatment (hormonal therapy alone).

To take part in this study, participants must first have surgery to remove their cancer. Participants who have lumpectomies, or breast conservation surgery, will receive radiation treatment. The doctor will submit a tissue sample from the cancer for a genomic test called Oncotype DX. This test looks at the genetic make-up of the cancer and assigns it a Recurrence Score based on the biology of the cancer. The higher the Recurrence Score, the more likely the cancer may recur.

Participants will be assigned to one of three treatment groups based on their Recurrence Score:

Group 1 participants have a Recurrence Score of 10 or less, meaning 95 percent of these cancers may be treated successfully with hormonal therapy alone. Because their cancer is unlikely to recur, participants in this group will receive hormonal treatment only.

Group 2 participants have a Recurrence Score of 26 or higher. People in Group 2 can reduce their risk of recurrence to 30 percent with hormonal therapy alone, but by adding chemotherapy can reduce their risk to 10 percent. Because people in this group have the highest risk of recurrence, they will receive combination chemotherapy and hormonal therapy.

Group 3 participants have a Recurrence Score of 11 to 25. Researchers want to learn whether these participants, whose scores fall in the middle of the range, need both combination chemotherapy and hormonal therapy to effectively treat their cancers. People in Group 3 will be randomly assigned to receive one of two treatments:

• Chemotherapy plus hormonal therapy (the standard treatment)
• Hormonal therapy alone (the investigational treatment)

Because only Group 3 participants are randomly assigned to receive a particular treatment, TAILORx is considered a semi-randomized clinical trial. Researchers use randomization to ensure their beliefs about the treatments do not influence the outcome of the study. By protecting the trial results from bias, researchers can feel confident they may be used successfully in day-to-day practice.

Goals of the TAILORx Trial

The primary goals of this trial are:

• To compare the disease-free survival, or the length of time after treatment that breast cancer does not recur, of women with an Oncotype DX Recurrence Score of 11 to 25 treated with combination chemotherapy to those who received hormonal therapy alone
• To compare these two groups to see which goes the longest without a distant recurrence of breast cancer, a local or regional recurrence or death from any cause
• To create a tissue and specimen bank of participants’ tumor specimens, tissue analyses, plasma and DNA from blood samples

Who Can Participate in TAILORx?

This large trial will recruit 10,046 women from cancer centers in the United States and abroad. Researchers will follow-up with study participants for up to 20 years after they finish the study treatment. You may be eligible to take part in this trial if you are between 18 and 75 years old and:

• Your cancer is estrogen-receptor positive and/or progesterone-receptor positive

• Your cancer is HER2/neu negative

• Your cancer has not spread to your lymph nodes

• Your tumor was between 1.1 and 5.0 centimeters

• You had surgery to remove the tumor within the last 84 days

• You have not yet received chemotherapy or radiation treatment for your cancer

• You have a tissue sample available from your primary tumor

• You are not pregnant or nursing

You may not participate in TAILORx if: you developed breast cancer while taking a preventive hormonal therapy (such as tamoxifen or raloxifene), or one of the aromatase inhibitors; you previously had breast cancer in the same or other breast or in both breasts; or you previously had ductal carcinoma in situ (DCIS) in the same or other breast.

For more information, contact: 1.800.4.CANCER

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