Table 1

Summary of current trials investigating the prognostic value of genomic signatures in primary node negative breast cancer

TRIAL

Study population

Lymph node

N

Sponsor

Study design

Randomisation procedure

Primary outcome

TAILORx

ER+ and/or PR+ Her2-ve Tumour size 1.1 to 5.0 cm

Tumour size 5 mm to 1.0 cm if poor risk features (LVI, high grade)

Negative

10,046

NCI

Oncotype DX assay to determine recurrence score (RS)

Group 1: RS <11; standard hormonal therapy

Group 2 (primary study group): RS 11 to 25

Group 3: RS >25; combination chemotherapy followed by hormonal therapy

Group 2: randomised to receive hormonal therapy alone or in combination with chemotherapy

DFS

Distant recurrence-free survival

Recurrence free survival

Overall survival

MINDACT

T1-3

Negative

6,000

EORTC

Establish Clinical Prognostic Risk (Adjuvant! Online) and Molecular Prognostic Risk scores based on 70-gene expression signature.

Patients divided into three categories:

1. HIGH/HIGH: concordant genomic and clinical risk

2. DISCORDANT RISK

3. LOW/LOW: concordant low risk

HIGH/HIGH: anthracycline based chemotherapy versus docetaxel/capecitabine

DISCORDANT RISK: randomisation to use Genomic or Clinical Risk scores to decide chemotherapy versus no chemotherapy

To establish whether patients with low risk molecular prognosis and high risk clinical prognosis can be safely spared chemotherapy

DFS, disease-free survival; EORTC, European Organisation for Research and Treatment of Cancer; ER, estrogen receptor; MINDACT, Microarray In Node negative Disease may Avoid ChemoTherapy; PR, progesterone receptor; RS, recurrence score; TAILORx, Trial Assigning IndividuaLized Options for Treatment (Rx).

Swanton et al. Breast Cancer Research 2008 10:214   doi:10.1186/bcr2159