Background
Phase 3, multicenter, open-label RCT (Korean Cancer Study Group BR 15-1); N=868; stage II–III early triple-negative breast cancer; 22 institutions in the Republic of Korea; randomized to anthracycline/taxane ± carboplatin as (neo)adjuvant therapy.
Results
Interventions and follow up: Arm A: Doxorubicin + cyclophosphamide (AC) → taxane + carboplatin (carboplatin arm)
Arm B: Doxorubicin + cyclophosphamide (AC) → taxane (control)
Primary endpoint: Event-free survival (EFS)
Secondary: OS, invasive DFS (iDFS), distant recurrence-free survival (DRFS), pCR, safety
mFollow up: 57.2 mo
Results: EFS: HR 0.67 (95% CI 0.49–0.92); P=.012; 5-yr EFS 82.3% vs 75.1% (absolute +7.2%)
pCR: 45.6% vs 39.3%
OS / iDFS / DRFS: directionally favored carboplatin, not statistically significant (NS)
Arm B: Doxorubicin + cyclophosphamide (AC) → taxane (control)
Primary endpoint: Event-free survival (EFS)
Secondary: OS, invasive DFS (iDFS), distant recurrence-free survival (DRFS), pCR, safety
mFollow up: 57.2 mo
Results: EFS: HR 0.67 (95% CI 0.49–0.92); P=.012; 5-yr EFS 82.3% vs 75.1% (absolute +7.2%)
pCR: 45.6% vs 39.3%
OS / iDFS / DRFS: directionally favored carboplatin, not statistically significant (NS)
Adverse events
Grade ≥3 treatment-related (any): 74.7% vs 56.7%
Main driver: hematologic toxicity
Quality of life: no clinically meaningful deterioration with carboplatin
Main driver: hematologic toxicity
Quality of life: no clinically meaningful deterioration with carboplatin
Conclusions
Adding carboplatin to standard anthracycline→taxane (neo)adjuvant chemotherapy significantly improved EFS in early-stage TNBC, with a manageable, predominantly hematologic increase in toxicity. Supports carboplatin incorporation into curative-intent TNBC chemotherapy.
Key Limitations
Open-label; single-country (Korea); pooled neoadjuvant + adjuvant populations; secondary endpoints (OS, iDFS, DRFS) not significant; enrollment (2016–2020) predates routine neoadjuvant pembrolizumab, so there is no immunotherapy backbone and carboplatin's contribution atop the current KEYNOTE-522 standard remains untested.
Clinical Context
KEYNOTE-522 (perioperative pembrolizumab + carboplatin/taxane → AC) is the current standard for stage II–III TNBC but cannot isolate carboplatin's contribution; PEARLY provides randomized evidence that carboplatin itself improves EFS. ASCO and ESMO already support adding carboplatin to neoadjuvant anthracycline–taxane chemotherapy in TNBC; PEARLY strengthens that position, particularly where immunotherapy is unavailable.