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 |