Trial reportBMJ (Clinical research ed.)2025
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.
Trial report in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04296175 (A Prospective, Single Center, Randomized, Open-labled Stage III Clinical Trial Comparing the Efficacy and Safety of Anthracyclin Followed by Weekly Paclitaxel Versus Dose-dense Anthracyclin Followed by Weekly Paclitaxel Versus Dose-dense Anthracyclin Followed by Weekly Paclitaxel Combined With Carboplatin for High-risk, Triple-negative Early Breast Cancer), which is not on this map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Single Center, Randomized, Open-labled Stage III Clinical Trial Comparing the Efficacy and Safety of Anthracyclin Followed by Weekly Paclitaxel Versus Dose-dense Anthracyclin Followed by Weekly Paclitaxel Versus Dose-dense Anthracyclin Followed by Weekly Paclitaxel Combined With Carboplatin for High-risk, Triple-negative Early Breast Cancer
Who cites it
5 citing papers in PubMed.
- Surgery-first versus neoadjuvant chemotherapy in stage I (cT1c) triple-negative breast cancer: A critical reappraisal.Breast (Edinburgh, Scotland) · 2026Review
- [Anthracycline use in breast cancer based on our current knowledge].Magyar onkologia · 2026Review
- Current and future therapies for triple-negative breast cancer.Journal of hematology & oncology · 2026Review
- Platinum-based neoadjuvant chemotherapy and the predictive role of DNA damage response biomarkers in TNBC: the NeoCarbo study.NPJ breast cancer · 2026Article
- AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2026.Breast care (Basel, Switzerland) · 2026Review
Corrections and comments
- Erratum issued
Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and safety of epirubicin and cyclophosphamide followed by weekly paclitaxel with or without carboplatin as adjuvant therapy for patients with high risk, early stage, triple negative breast cancer.
designRandomised, open label, phase 3 trial.
settingFudan University Shanghai Cancer Center in China between March 2020 and March 2022.
participantsFemale patients with operable high risk triple negative breast cancer (defined as either regional node positive or node negative with a Ki-67 labelling index of ≥50%) after definitive surgery.
interventionsPatients were randomised in a 1:1 ratio into either the carboplatin arm (four cycles of two weekly epirubicin and cyclophosphamide followed by four cycles of weekly paclitaxel combined with carboplatin) or the control arm (four cycles of three weekly or two weekly epirubicin and cyclophosphamide followed by four cycles of weekly paclitaxel).
main outcome measuresThe primary endpoint was disease-free survival in the intention-to-treat population. Secondary endpoints included recurrence-free survival, distant disease-free survival, overall survival, and safety.
resultsOf the 808 enrolled patients, 807 received study treatment. At a median follow-up of 44.7 months, estimated percentages of patients who would be disease-free at three years were 92.3% in the carboplatin arm and 85.8% in the control arm (hazard ratio 0.64, 95% confidence interval (CI) 0.43 to 0.95; P=0.03). However, the assessment of the proportional hazards assumption showed that it was violated (P=0.02). A piecewise hazard model showed that the hazard ratio changed over time: the hazard ratio was 0.31 (95% CI 0.13 to 0.73) for 0-12 months, 0.65 (0.39 to 1.09) for 12-36 months, and 1.98 (0.69 to 5.69) for >36 months. For secondary endpoints, the carboplatin arm was associated with improved outcomes in three year recurrence-free survival (93.8%
conclusionsThe addition of carboplatin to adjuvant anthracycline/taxane based chemotherapy significantly improved survival outcomes in patients with high risk, early stage, triple negative breast cancer, driven by reduction of early recurrence risk without new safety concerns.
trial registrationClinicalTrials.gov NCT04296175.
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