Table 3.
Current combination treatments in TNBCs.
| S. No. | Treatment | TNBC cases | Cohort | Clinical Phase | Status | References |
|---|---|---|---|---|---|---|
| A. | Current clinical trials of ICIs involving patients with metastatic/early stage TNBC | |||||
| 1. | Nab-paclitaxel+atezolizumab | 33 | mTNBC | Ib/III | ORR: 39.4%, mPFs: 5.5mo, mOS 14.7mo. | (203, 272) |
| 2. | Ipatasertib and atezolizumab plus either nab-paclitaxel | 26 | mTNBC | Ib | ORR: 73% | (203) |
| 3. | Ladiratuzumab vedotin + pembrolizumab | 26 | mTNBC | Ib/II | ORR: 54% | (203) |
| 4. | Durvalumab + trastuzumab deruxtecan | 21 | mTNBC | Ib/II | ORR: 66.7% | (203, 273) |
| 5. | Eribulin + pembrolizumab | 167 | mTNBC | Ib/II | ORR: 23.4, mPFS: 4.1mo, mOS: 16.1mo. | (203, 274) |
| 6. | Atezolizumab+taxanes+MEKi | 902 | Locally advanced/mTNBC | II | Active/ORR: 29%-34% | (275) |
| 7. | Pembrolizumab +MEKi | 12 | Locally advanced/mTNBC | I/II | Recruiting | (275) |
| 8. | Cobimetinib and atezolizumab + either nab-paclitaxel/paclitaxel | 63 | mTNBC | II | ORR: 31.7% | (203, 276) |
| 9. | Entinostat + atezolizumab | 40 | mTNBC | II | ORR: 10%; mPFS: 1.68mo; mOS: 9.4mo. | (203) |
| 10. | Lenvatinib + pembrolizumab | 31 | mTNBC | II | ORR: 29% | (203) |
| 11. | Paclitaxel + atezolizumab/placebo | 651 | mTNBC | III | ORR in ITT: 53.6 vs. 47.5% | (203, 277) |
| 12. | GX-17 + pembrolizumab | 30 | mTNBC | Ib/II | ORR: 13.3% | (203) |
| 13. | Nab-paclitaxel+atezolizumab/placebo | 902 | mTNBC | III | ORR: 45.9% | (277) |
| 14. | Pembrolizumab + nab-paclitaxel/paclitaxel/gemcitabine/carboplatin | 882 | mTNBC | III | PFS: 9mo. | (19, 275) |
| 15. | Pembrolizumab + gemcitabine/carboplatin | 87 | mTNBC | II | Pending | (275) |
| 16. | Pembrolizumab + eribulin mesylate | 167 | mTNBC | Ib/II | ORR: 25%; PFS: 4.1mo. | (275) |
| 17. | Nivolumab after Cyclophosphamide/cisplatin/doxorubicin | 66 | mTNBC | II | ORR: 35% (Doxorubicin); | (275) |
| 18. | Atezolizumab +nab-paclitaxel | 900 | Locally advanced/mTNBC | III | ORR: 53%; OS: 25mo | (166, 275) |
| 19. | Atezolizumab + paclitaxel | 600 | Locally advanced/mTNBC | III | Pending | (275) |
| 20. | Atezolizumab + gemcitabine/carboplatin or capecitabine | 540 | Locally advanced/mTNBC | I | Recruiting | (275) |
| 21. | Atezolizumab + paclitaxel followed by atezolizumab +AC or EC | 2,300 | Locally advanced | III | Recruiting | (275) |
| 22. | Neoadjuvant pembrolizumab + paclitaxel and AC | 114 | Locally advanced | II | Recruiting | (275, 278) |
| 23. | Neoadjuvant pembrolizumab + chemotherapy combination (Nab-paclitaxel, paclitaxel, doxorubicin, Cyclophosphamide, carboplatin | 60 | Locally advanced | I | Completed, pCR: 60% | (275) |
| 24. | Neoadjuvant pembrolizumab + paclitaxel-carboplatin followed by adjuvant pembrolizumab | 1,174 | Locally advanced | III | pCR: 64.8% | (279) |
| 25. | Paclitaxel ± Pembrolizumab followed by adjuvant thaerpy | 114 | Early Stage | II | pCR: 60% vs. 22% | (203) |
| 26. | Nab-paclitaxel+durvalumab/placebo followed by endocrine therapy+durvalumab/placebo | 174 | Early Stage | II | pCR in ITT: 53.4% vs. 44.2% | (203) |
| 27. | Pembrolizumab+anthracycline+taxane-based chemotherapy ± carboplatin followed by adjuvant chemotherapy | 60 | Early Stage | ib | pCR overall: 60% | (203) |
| 28. | Nab-paclitaxel+atezolizumab/placebo followed by adjuvant chemotherapy+atezolizumab/placebo | 313 | Early Stage | III | pCR in ITT: 58% vs. 41% | (203, 280) |
| 29. | Anthracycline, taxane and carboplatin+Pembrolizumab/placebo followed by adjuvant chemotherapy/endocrine therapy | 1,174 | Early Stage | III | pCR: 63% vs. 55% | (203, 281) |
| 30. | Nab-paclitaxel+acarboplatin ± atezolizumab | 280 | Early Stage | III | pCR in ITT: 43.5% vs. 40.8% | (203) |
| 31. | Neoadjuvant atezolizumab+paclitaxel+carboplatin followed by atezolizumab +AC or EC | 1520 | Early Stage | III | Recruiting | (203) |
| 32. | Atezolizumab + carboplatin + nab-paclitaxel | 278 | Early/Locally advanced/mTNBC | III | Active/not recruiting | (215) |
| 33. | Atezolizumab + neoadjuvant chemotherapy | 1550 | TNBC | III | Active/not recruiting | (215) |
| 34. | Atezolizumab + nabpaclitaxel | 184 | Locally advanced/mTNBC | III | Active/not recruiting | (215) |
| 35. | Atezolizumab + chemotherapy | 572 | Locally advanced/mTNBC | III | Recruiting | (215) |
| 36. | Atezolizumab + adjuvant anthracycline/taxane based therapy | 2300 | Locally advanced/mTNBC | III | Recruiting | (215) |
| 37. | Atezolizumab + ipataseritib and paclitaxel | 242 | mTNBC | III | Active/not recruiting | (215) |
| 38. | Avelumab as adjuvant or post-neoadjuvant | 474 | Locally advanced/mTNBC | III | Active/not recruiting | (215) |
| 39. | Camrelizumab + Chemotherapy | 581 | Locally advanced/mTNBC | III | Recruiting | (215) |
| 40. | Serplulimab + chemotherapy | 522 | Locally advanced/mTNBC | III | Not recruiting | (215) |
| 41. | Toripalimab + nab-paclitaxel | 531 | Locally advanced/mTNBC | III | Recruiting | (215) |
| 42. | Carelizumab + nab-paclitaxel + apatinib vs. Carelizumab+nab-paclitaxel vs. nab-paclitaxel | 80 | Locally advanced/mTNBC | III | Recruiting | (215) |
| 43. | TQB2450 + anlotinib hydrochloride/paclitaxel | 332 | TNBC | III | Not recruiting | (215) |
| 44. | Anti-Globo-H-Vaccine adagloxad simolenin (OBI-822)/OBI-821 | 668 | Early Globo-H+ TNBC | III | Recruiting | (215) |
| B. | Current trials of combination chemotherapeutic agents involving patients with metastatic/early stage TNBC | |||||
| 1. | Ixabepilone+capecitabine vs. capecitabine | 443 | mTNBC | III | PFS: 4.2 vs. 1.7mo.; OS: 9.0 vs. 10.4 mo. | (215) |
| 2. | Pacitaxel+carboplatin vs. cyclophosphamide+epirubicin+fluorouracil+docetaxel | 647 | TNBC | III | DFS: 86.5 vs. 80.3% | (215) |
| 3. | Docetaxel+epirubicin ± lobaplatin | 125 | TNBC | II | pCR: 93% vs.73% | (215) |
| 4. | Cisplatin+gemcitabine vs. paclitaxel+gemcitabine | 236 | mTNBC | III | PFS: 7.7 vs. 6.47mo. | (215) |
| C. | Current trials of PARP inhibitor involving patients with metastatic/early stage TNBC | |||||
| 1. | Veliparib/Paclitaxel/carboplatin vs. Paclitaxel/carboplatin vs. Paclitaxel | 634 | Early Stage | III | pCR: 53% vs.58% | (215) |
| 2. | Veliparib+carboplatin | 72 | Locally advanced/mTNBC | II | pCR51%vs.26% | (215) |
| 3. | Paclitaxel/carboplatin ± olaparib | 527 | Early stage TNBC | II/III | pCR15 to 20% | (275) |
| 4. | Olaparib + Pembrolizumab vs. carboplatin/gemcitabine | 932 | Locally advanced/mTNBC | II/III | Recruiting | (282) |
| 5. | Olaparib + durvalumab | 17 | mTNBC | I/II | ORR: 58.8%; mPFS: 4.9mo; mOS: 20.5mo. | (203, 283) |
| 6. | Niraparib + pembrolizumab | 45 | mTNBC | I/II | ORR: 29.0%; mPFS 2.3mo. | (203, 284) |
| 7. | Atezolizumab + olaparib | 81 | Locally advanced/mTNBC | II | Active/Not-recruiting | (275) |
| 8. | Iniparib+ gemcitabine/carboplatin | 80 | Early Stage TNBC | II | pCR: 36% | (215) |
| D. | Current trials of AKT inhibitor involving patients with metastatic/early stage TNBC | |||||
| 1. | Paclitaxel ± ipatasertib | 450 | Locally advanced/mTNBC | III | PFS: 9.3mo; ORR: 47% | (282) |
| 2. | Paclitaxel+ipatasertib or placebo | 124 | Locally advanced/mTNBC | II | PFS: 6.2 vs. 4.9 mo. | (215) |
| 3. | Ipatasertib+paclitaxel or placebo | 151 | Early stage TNBC | II | pCR: 17% vs. 13% | (215) |
| 4. | Paclitaxel ± capivasertib | 800 | Locally advanced/mTNBC | III | Recruiting | (282) |
| 5. | Paclitaxel + capivasertib or placebo | 140 | mTNBC | II | PFS: 5.9 vs. 4.2 mo. | (215) |
| 6. | Paclitaxel/ipatasertib/Atezolizumab vs. Paclitaxel/ipatasertib vs. Paclitaxel | 450 | Locally advanced/mTNBC | III | Recruiting | (282) |
| E. | Current trials of PI3K inhibitor involving patients with metastatic/early stage TNBC | |||||
| 1. | Nab-paclitaxel ± alpelisib | 566 | Locally advanced | III | Pending | (282) |
| 2. | Paclitaxel+buparlisib or placebo | 416 | mTNBC | II/III | PFS: 8.0 vs. 9.2 mo. | (215) |
| 3. | Camrelizumab+apatinib or intermittent apatinib | 40 | mTNBC | PFS: 3.7 vs. 1.9 mo. | (215) | |
| F. | Current trials of VEGF/VEGFR inhibitor involving patients with metastatic/early stage TNBC | |||||
| 1. | Paclitaxel+carboplatin vs. cyclophosphamide+carboplatin+/or bevacizumab | 443 | mTNBC | III | pCR: 93.5% vs. 73.0% | (215) |
| 2. | Anthracycline+taxane± bevacizumab | 493 | TNBC | III | pCR: 50% | (215) |
| 3. | Paclitaxel+doxorubicin+ bevacizumab±;carboplatin | 315 | TNBC | II | pCR: 53% vs. 36.9% | (215) |
| G. | Current trials in combination with cancer vaccine involving patients with metastatic/early stage TNBC | |||||
| 1. | Pembrolizumab+PX-410 | 20 | TNBC | I | Active/ Not-recruiting |
(215) |
| 2. | Pembrolizumab+p53-MVA | 11 | TNBC | I | Active/ Not-recruiting |
(215) |
| 3. | Durvalumab+PX-410 | 22 | TNBC | I | Active/ Not-recruiting |
(215) |
| 4. | Durvalumab+neo-antigen DNA vaccine | 18 | TNBC | I | Active/ Not-recruiting |
(215) |
| 5. | Durvalumab+nab-paclitaxel+neo-antigen DNA vaccine | 70 | TNBC | II | unknown | (215) |
| 6. | Atezolizumab+neo-antigen DNA vaccine | 272 | TNBC | I | Active/ Not-recruiting |
(215) |
ICIs, Immune checkpoint inhibitors; mTNBC, metastatic TNBC; pCR, Pathological complete response; PFS, Progression free survival; mPFS, mean progression free survival; ORR, Objective response rate; mOS, Mean objective survival, ITT, Intention to treats; mo., month.