TABLE 3.
Summary of ongoing and recently reported clinical trials with Pt derivatives and taxane combinations in triple-negative breast cancer.
| phase | NCT | Study population | Setting | Stage | Experimental arm | Control arm | Primary endpoint |
|---|---|---|---|---|---|---|---|
| II | NCT01042379 | TNBC | Neoadjuvant | II–III | Veli + Cb → standard NACT | Standard NACT | pCR |
| III | NCT02032277 (BrighTNess) | TNBC | Neoadjuvant | II–III | Veli + Cb + P → AC | Placebo + Cb + P → AC | pCR |
| II/III | NCT03150576 (PARTNER) | TNBC and/or gBRCA mutated BC | Neoadjuvant | II–III | Ola + Cb + P → AC/EC | P + Cb → AC/EC | Safety, pCR |
| II | NCT03639948 (NeoPACT) | TNBC | Neoadjuvant | I–III | Cb + T + pembro | NA | pCR |
| III | NCT02620280 (NeoTRIPaPDL1) | High-risk TNBC | Neoadjuvant | II–III | Cb + nab-P + atezo → AC/EC/FEC | Cb + nab-P → AC/EC/FEC | EFS |
| III | NCT03036488 (Keynote-522) | TNBC | Neoadjuvant | II–III | Cb + P + pembro → AC/EC + pembro | Cb + P + placebo → AC/EC + placebo | pCR, EFS |
| III | NCT03281954 (NSABP B-59) | TNBC | Neoadjuvant | II–III | P + Cb + atezo → atezo + AC/EC | P + Cb + placebo → placebo + AC/EC | pCR, EFS |
| II | NCT03872505 (PANDoRA) | TNBC | Neoadjuvant | II–III | Durva + Cb + P + radiation | Durva + Cb + P | pCR |
| II | NCT03650738 | TNBC | Neoadjuvant | II–III | Apatinib + nab-P + Cb | NA | pCR, safety |
| II | NCT03193853 | TNBC | Neoadjuvant | IV | Tak-228 + Tak-117 → cis + nab-P | NA | ORR |
| II/III | NCT02221999 | TNBC and Hormone-receptor-positive | Neoadjuvant | III-IV | P + cis + leuprolide/goserelin versus P + cis + letrozole | P + cis | pCR |
| II | NCT04537286 | TNBC | Neoadjuvant | IV | Nab-P + cis + carilizumab | NA | PFS, safety |
| II | NCT04159142 | TNBC | Neoadjuvant | III | Nab-P + Cb | Nab-P + capecitabine | PFS |
| II | NCT03121352 | TNBC | Neoadjuvant | IV | Cb + nab-P + pembro | NA | ORR |
| II | NCT04083963 (BRE-01) | TNBC | Neoadjuvant | I-IV | P + Cb → AC/EC | NA | pCR |
| II | NCT02876107 | TNBC | Neoadjuvant | I-III | P + Cb + panitumumab | P + Cb | pCR |
| II | NCT02124902 | TNBC | Neoadjuvant | II–III | T + Cb | T + Cb | pCR |
| IV | NCT04136782 | TNBC | Neoadjuvant | II-III | Nab-P + Cb | E + T | pCR |
| II | NCT02547987 (CADENCE) | TNBC | Neoadjuvant | II-III | T + Cb | NA | pCR |
| II | NCT01525966 | TNBC | Adjuvant | II–III | Cb and nab-P | NA | pCR |
| III | NCT02455141 (TCTN) | TNBC | Adjuvant | EC → P or T | EC → P or T + Cb | DFS | |
| III | NCT03876886 | TNBC | Adjuvant | II-III | AC + P | P + Cb | DFS |
| III | NCT02441933 (PEARLY Trial) | TNBC | Adjuvant/Neoadjuvant | II-III | AC → P or T + Cb | AC→ P or T | DFS |
A, doxorubicin; Atezo, atezolizumab; C, cyclophosphamide; Cb, carboplatin; Cis, cisplatin; DFS, Disease-free survival; Durva, durvalumab; EFS, event-free survival; E, epirubicin; F,5-fluorouracil; NA, not available’ nab-P, albumin paclitaxel (weekly cycle if not specially noted); ORR, objective response rate; Ola, olaparib, P, paclitaxel (weekly cycle if not specially noted), PCR, pathological complete response, Pembro, pembrolizumab; RFS, Relapse-free survival; T, docetaxel; TNBC, triple negative breast cancer; Veli, veliparib.