Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial

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Source: BMJ

Original: http://www.bmj.com/content/391/bmj-2025-085457.short?rss=1...

Published: 2025-12-23T02:10:52-08:00

The CITRINE trial was a randomized, open-label, phase 3 trial comparing adjuvant chemotherapy with the addition of carboplatin (epirubicin + cyclophosphamide followed by weekly paclitaxel + carboplatin) with standard chemotherapy (epirubicin + cyclophosphamide followed by weekly paclitaxel) in 807 patients with high-risk early triple-negative breast cancer after surgery. High risk meant positive regional nodules or negative nodules with Ki-67 ≥ 50%. At a median follow-up of 44.7 months, the 3-year disease-free survival was 92.3% in the carboplatin arm versus 85.8% in the control arm (hazard ratio 0.64, 95% CI 0.43-0.95; P=0.03), although the proportional hazards assumption was violated. The hazard ratios varied: 0.31 (0-12 months), 0.65 (12-36 months) and 1.98 (>36 months). Secondary endpoints showed better 3-year outcomes in the carboplatin arm: recurrence-free survival 93.8% vs. 88.3% (hazard ratio 0.59; P=0.02), distant disease-free survival 94.8% vs. 89.8% (hazard ratio 0.61; P=0.04), and overall survival 98.0% vs. 94.0% (hazard ratio 0.41; P=0.01). Grade 3-4 adverse events occurred in 66.7% of patients in the carboplatin arm versus 55.0% in the control arm, with no treatment-related deaths. The addition of carboplatin improved survival by reducing the risk of early recurrence with no new safety issues.