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

1. Among patients with high-risk, early-stage triple-negative breast cancer, the addition of carboplatin to a standard anthracycline/taxane adjuvant chemotherapy regimen significantly improved survival outcomes with a reduction in early recurrence risk. 

Evidence Rating Level: 1 (Excellent)

Among the classical subtypes of breast cancer, triple-negative breast cancer is an aggressive disease with higher early recurrence than other subtypes. Neoadjuvant treatment is typically recommended for patients with stage 2 or 3 disease. However, the optimisation of adjuvant regimens for patients with high-risk triple-negative disease remains a topic of investigation. This randomised clinical trial therefore sought to investigate the safety and efficacy of epirubicin and cyclophosphamide, followed by weekly paclitaxel, with and without carboplatin as adjuvant therapy for patients with high-risk triple-negative breast cancer. Between March 2020 and March 2022, 808 patients (median age[range], 47[22-70] years) from the Fudan University Shanghai Cancer Centre were randomised in a 1:1 ratio to either a control group receiving standard chemotherapy or a carboplatin group. The primary outcome was disease-free survival. At 3 years, 92.3% of patients in the carboplatin group were disease-free, compared to 85.5% in the control group (unadjusted hazard ratio 0.64, 95% confidence interval (CI) 0.43 to 0.95; P=0.03). Additionally, patients in the carboplatin group had a statistically significantly greater overall survival than patients in the control group (98.0% versus 94.0%; hazard ratio 0.41, 0.20 to 0.83; P=0.01). Overall, this study found that among patients with high-risk, early-stage triple-negative breast cancer, the addition of carboplatin to standard chemotherapy significantly improved survival outcomes.

Click here to read this study in BMJ

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