Active not recruitingPHASE3INTERVENTIONAL

Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

This research trial, called TAILORx, is for women who have had surgery for a common type of early breast cancer. This breast cancer is hormone-sensitive and has not spread to the lymph nodes. Researchers want to find the best way to treat these women after surgery. A special test, called Oncotype DX, helps predict the chance of the cancer coming back. The study compares giving hormone therapy alone to giving hormone therapy alongside chemotherapy for women whose test results show a moderate risk of the cancer returning. The aim is to see which approach works better with fewer side effects, helping doctors make more personalised treatment decisions.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

National Cancer Institute (NCI)

Enrolment target

10,273

Start

07 Apr 2006

Estimated completion

30 Sep 2030

Breast Adenocarcinoma Hormone Receptor Positive Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage IIIB Breast Cancer AJCC v7

What is this study about?

Imagine you or someone you know has been diagnosed with breast cancer that is found early and hasn't spread to nearby lymph nodes. This type of cancer often responds to hormones in the body, so doctors often suggest hormone therapy. Sometimes, they also recommend chemotherapy. But how do they know who truly needs chemotherapy, which can have significant side effects?

This study, called TAILORx, aims to help answer that very question for women with this specific type of early breast cancer. Doctors use a special test called Oncotype DX. This test looks at certain genes in the cancer cells to help predict how likely the cancer is to come back and how much benefit chemotherapy might offer. For women with a low risk, hormone therapy alone is often recommended. For those with a higher risk, chemotherapy is usually added.

However, for women with a "medium" risk score on this test (scores between 11 and 25), it's not always clear whether adding chemotherapy is truly beneficial. This trial is designed to find out if hormone therapy alone is just as good, or if adding chemotherapy makes a noticeable difference for these women. By comparing these two approaches, the hope is to avoid unnecessary chemotherapy for some women, reducing side effects while still providing excellent care. This research is important because it could help doctors tailor treatments more precisely to each individual patient, improving quality of life without compromising effectiveness.

Key takeaways

This study is for women with a common type of early breast cancer that's hormone-sensitive and hasn't spread to lymph nodes.
It uses a special test (Oncotype DX) to help decide the best treatment plan.
The study compares hormone therapy alone vs. hormone therapy plus chemotherapy.
The goal is to find out if some women can safely avoid chemotherapy, reducing side effects.
Participation involves ongoing monitoring for up to 10 years.

Who may be eligible?

This study is looking for women who have had surgery for breast cancer. To join, your breast cancer must meet specific criteria:

Firstly, your cancer must be sensitive to hormones (meaning it's 'hormone receptor positive') and importantly, it must not have spread to your lymph nodes. Your tumour should typically be between 1.1 cm and 5 cm in size, though smaller tumours (5 mm to 1 cm) might be included if they have certain features like a higher grade or signs of growing into tiny blood vessels. Also, your cancer must be 'HER2 negative', a different protein often found in some breast cancers.

Finally, you need to be between 18 and 75 years old. Your doctors will also need to be able to get a sample of your tumour tissue to perform the special Oncotype DX test, which will help decide if this study is suitable for you.

Quick self-check

Are you a woman diagnosed with breast cancer?
Has your breast cancer been surgically removed and not spread to your lymph nodes?
Is your breast cancer 'hormone receptor positive'?
Is your breast cancer 'HER2 negative'?
Are you between 18 and 75 years old?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the process would generally involve several steps. First, your doctors would take a sample of your breast tumour, usually from your surgery, to send for a special test called Oncotype DX. This test helps determine your risk score and which treatment group would be best for you in the study.

Depending on your test results, you would be randomly assigned to either receive hormone therapy alone or hormone therapy combined with chemotherapy. Hormone therapy involves taking medication, usually as a tablet, for several years. Chemotherapy involves specific drugs often given through a vein over several months. You would have regular check-ups with your medical team to monitor your health, side effects, and the effectiveness of the treatment.

The study would involve ongoing follow-up for up to 10 years to see how well the treatments work in the long term and to track any changes in your health. This might include regular doctor visits and possibly some quality-of-life questionnaires to understand how you are feeling.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that it might help clarify the best treatment approach for your specific type of breast cancer, potentially allowing you to avoid chemotherapy if it's not truly needed, thereby reducing side effects. You would also be closely monitored by a medical team. However, there are risks associated with both hormone therapy and chemotherapy, including side effects that can range from mild to severe, and there's always a chance the treatment might not work as hoped. You are free to withdraw from the study at any time without affecting your standard medical care.

Locations (1223)

Northeast Alabama Regional Medical Center
Anniston, United States
University of Alabama at Birmingham Cancer Center
Birmingham, United States
Mobile Infirmary Medical Center
Mobile, United States
Providence Hospital
Mobile, United States
University of South Alabama Mitchell Cancer Institute
Mobile, United States
Alaska Regional Hospital
Anchorage, United States
Providence Alaska Medical Center
Anchorage, United States
Fairbanks Memorial Hospital
Fairbanks, United States
Banner Thunderbird Medical Center
Glendale, United States
Banner Desert Medical Center
Mesa, United States
Banner Baywood Medical Center
Mesa, United States
Banner-University Medical Center Phoenix
Phoenix, United States

+1211 more sites — see the official record for the full list.

Common questions

What is 'node-negative' breast cancer?

This means the cancer has not spread to the lymph nodes (tiny glands that are part of your immune system) that are usually near the breast.

What is a 'hormone receptor-positive' breast cancer?

This means the cancer cells have special proteins (receptors) that attach to hormones like oestrogen. These hormones can help the cancer grow, so treatments often aim to block this process.

What is the Oncotype DX test?

It's a special test done on your tumour tissue after surgery. It looks at certain genes to predict how likely your breast cancer is to come back and how much benefit you might get from chemotherapy.

What's the difference between hormone therapy and chemotherapy?

Hormone therapy targets cancer cells that are sensitive to hormones, often by blocking the effect of oestrogen. Chemotherapy uses strong drugs to kill fast-growing cells, including cancer cells, throughout the body.

Why is this study important?

It aims to help doctors understand if some women with a moderate risk of their cancer returning might be able to avoid chemotherapy, reducing side effects while still getting effective treatment.