Trial assigning individualised options for treatment (TAILORx trial)

31 August 2010

 

Purpose

To investigate the use of the Oncotype DX assay, a specialised laboratory test to predict breast cancer recurrence in women with early stage hormone receptor positive and node negative breast cancer. The aim of the research is to investigate whether women with an intermediat eOncotype DX breast cancer recurrence score (11-25) benefit from chemotherapy in addition to endocrine treatment.

Scientific Title

A phase III, multicentre, multinational, randomised trial of adjuvant chemotherapy plus hormone treatment versus adjuvant hormone treatment alone for patients with previously resected, axillary node-negative, invasive breast cancer with various levels of risk for recurrence.

Short title: Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for TReatment: The TAILORx Trial

Background

Breast cancer treatment usually involves one or more of the following options – surgery, chemotherapy, hormone therapy and radiotherapy.  Traditionally, the choice and combination of treatments depends on factors such as the type, size and aggressiveness of the breast cancer, whether it is hormone (oestrogen and progesterone) receptor positive or not, and whether the cancer has spread to the lymph nodes in the armpit/axilla. Chemotherapy is often recommended for the treatment of early breast cancer to lower the risk of the breast cancer returning. However, doctors now recognise that chemotherapy benefits some early breast cancer patients more than others, and may be unnecessary altogether for certain patients.

The TAILORx trial involves the use of a diagnostic test called the Oncotype DX Breast Cancer Assay. The Oncotype DX Assay measures the levels of a specific set of 21 genes in a breast tumour. Looking at the levels of these genes helps researchers and doctors better estimate a patient’s individual risk of cancer recurrence. The results of this test are entered into a computer which produces a score between 0 – 100, known as a Recurrence Score (RS). A RS of < 10 indicates a low risk breast cancer and chemotherapy isn’t recommended, and a RS of > 26 indicates a high risk breast cancer and chemotherapy is recommended. The TAILORx trial has investigated whether or not women with a RS of 11-25 (intermediate risk) would benefit (or not) from chemotherapy.

Enrolment: Closed