Table 1 Features and outcomes of the main randomized chemo-immunotherapy trials in early-stage triple negative breast cancer.

From: Immunotherapy for early triple negative breast cancer: research agenda for the next decade

Trial name

Phase

Primary endpoint

Population enrolled

Regimen

pCR outcome (95% CI), %

Survival outcomes

KEYNOTE-522

3

pCR and EFS in ITT

Untreated stage II–III TNBC patients (n = 1174)

Neoadjuvant TCb -> AC ± pembro, followed by pembro (or placebo) for 1 year after surgery

64.8% vs 51.2%; delta 13.6% (5.4–21.8), p < 0.001

3-year EFS 84.5% vs 76.8% (HR 0.63, 95% CI 0.48–0.82, p = 0.0003)

3-year DDFS 87% vs 80.7% (HR 0.61, 95% CI 0.46-0.82)

3-year OS 89.7% vs 86.9% (HR 0.72, 95% CI 0.51–1.02, p = 0.032)

Impassion031

3

pCR in ITT and in PD-L1 + patients

Untreated stage II–III TNBC patients (n = 333)

Neoadjuvant nabT -> AC ± atezo, followed by atezo (or placebo) for 1 year after surgery (capecitabine also allowed)

58% vs 41%; delta 17% (6–27), p = 0.0044

EFS HR 0.76 (95% CI 0.40–1.40)

DFS HR 0.74 (95% CI 0.32–1.70)

OS HR 0.69 (95% CI 0.25–1.87)

NeoTRIPaPDL1

3

EFS

Untreated stage II–III TNBC patients (n = 280)

Neoadjuvant nabTCb ± atezo followed by adjuvant anthracyclines after surgery

43.5% vs 40.8%; OR, 1.11 (0.69–1.79), p = 0.66

Pending

GeparNuevo

2

pCR in ITT

Untreated stage I–III TNBC patients (n = 174)

Neoadjuvant nabT -> AC ± durva followed by physician’s choice of adjuvant treatment after surgery

53.4% vs 44.2%; OR, 1.45 (0.80–2.63), p = 0.287

3-year iDFS 84.9% vs 76.9% (HR 0.54, 95% CI 0.27–1.09, p = 0.0559)

3-year DDFS 91.4% vs 79.5% (HR 0.37, 95% CI 0.15–0.87, p = 0.0148)

3-year OS 95.1% vs 83.1% (HR 0.26, 95% CI 0.09–0.79, p = 0.0076)

I-SPY2

2

pCR in ITT

Untreated stage II–III TNBC and HR+/HER2- BC patients (n = 107)

Neoadjuvant T - > AC ± pembro followed by physician’s choice of adjuvant treatment after surgery

60% (44–75) vs 22% (13–20) (TNBC patients)

EFS HR 0.60 (TNBC patients)

  1. AC anthracyclines plus cyclophosphamide, atezo atezolizumab, BC breast cancer, Cb carboplatin, DFS disease-free survival, DDFS distant disease-free survival, durva durvalumab, EFS event-free survival, HER2 human epidermal growth factor receptor 2, HR+ hormone receptors positive, iDFS invasive disease-free survival, nabT nab-paclitaxel, OR odds ratio, OS overall survival, pembro pembrolizumab, pCR pathological complete response, T taxane (paclitaxel or docetaxel), TNBC triple negative breast cancer.
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