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. 2018 May 3;3(Suppl 1):e000357. doi: 10.1136/esmoopen-2018-000357

Table 3.

Ongoing clinical trials of immune checkpoint inhibitors for patients with early-stage TNBC

Phase NCT ID Defined breast cancer subtype Setting Stage Experimental drugs Control Primary endpoint
IO monotherapy
 III SWOG1418
(NCT02954874)		 Residual TNBC
(ypT>1 cm or ypN+)		 Adjuvant after NAC NA Pembrolizumab for 1 year Observation as per guideline Invasive DFS (IDFS)
 III NCT02926196 High-risk TNBC Adjuvant or post-NAC NA Avelumab for 1 year Observation as per guideline

  • Overall DFS

  • DFS in PD-L1(+) patients
IO-based combination
 II I-SPY 2
(NCT01042379)
*Neoadjuvant, personalised adaptive trial with novel agents		 LABC including TNBC Neoadjuvant II, III

  • Pembrolizumab+Paclitaxel

  • Followed by Doxorubicin+Cyclopho

  • sphamide

 Standard NAC pCR: 62.4% vs 22.3%
 IB KEYNOTE-173
(NCT02622074)		 Locally advanced TNBC Neoadjuvant II, III (Arm A)

  • Pembrolizumab → Pembrolizumab+Nab paclitaxel

(Arm B)

  • Arm A+Carboplatin

  • Followed by ddAC

 NA pCR (Arm A vs B): 60% vs 90%
 III KEYNOTE-522
(NCT03036488)		 TNBC Neo/adjuvant NA (Neoadjuvant)

  • Pembrolizumab+wPaclitaxel +  Carboplatin (4C) →Pembrolizumab+AC (4C)

(Adjuvant)

  • Pembrolizumab (9C)

 Placebo rather than Pembrolizumab pCR, EFS
 I/II NCT02489448 TNBC Neoadjuvant I–III

  • Durvalumab+Nab paclitaxel for 12 weeks

  • Followed by ddAC

 NA pCR
 II Triple-negative first-line study (NCT02530489) TNBC (Neo)adjuvant NA

  • Neo: Atezolizumab+Nab paclitaxel (4C)

  • Adj: Atezolizumab alone (4C)

 NA pCR
 III NeoTRIPaPDL1
(NCT02620280)		 Locally advanced TNBC Neoadjuvant NA Atezolizumab+Nab-paclitaxel+Carboplatin Nab-paclitaxel+Carboplatin EFS
 Ib NCT02826434 TNBC Adjuvant II/III

  • Peptide vaccine PVX-410 (six infusions)+Durvalumab (2C)

  • After standard adjuvant chemotherapy

 NA DLT of PVX-410 in combination with Durvalumab

(dd)AC, (dose-dense) doxorubicin and cyclophosphamide; DFS, disease-free survival; DLT, dose-limiting toxicity; EFS, event-free survival; IDFS, invasive DFS; LABC, locally advanced breast cancer; NA, not available; NAC, neoadjuvant chemotherapy; pCR, pathologic complete response; PD-L1, programmed death ligand 1; TNBC, triple-negative breast cancer.