MINDACT — Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy

Phase 3 · 2016 · Breast Cancer

Design

Prospective, randomized phase 3 trial evaluating the 70-gene MammaPrint signature combined with standard clinical-pathological criteria to select early breast cancer patients for adjuvant chemotherapy.

Population

Women with early-stage breast cancer with 0 to 3 positive lymph nodes.

Primary Endpoint

5-year distant metastasis-free survival

Key Result

Among patients at high clinical risk but low genomic risk, 5-year distant metastasis-free survival without chemotherapy was 94.7% (95% CI 92.5-96.2), only 1.5 percentage points lower than with chemotherapy, supporting chemotherapy omission in this discordant group.

Guideline Impact

Supported use of 70-gene MammaPrint to guide chemotherapy decisions in early breast cancer