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Table 1 Summary of current trials investigating the prognostic value of genomic signatures in primary node negative breast cancer

From: Functional genomic analysis of drug sensitivity pathways to guide adjuvant strategies in 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
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
  1. 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).