Table 2. Neoadjuvant triple-negative breast cancer clinical trials post-2010 showing pathological complete response rates with combinations of chemotherapy, PARP inhibitors and novel agents.
| Study
Phase ClinicalTrials.gov Identifier |
Number of
patients |
Trial arms | Pathological complete
response |
|---|---|---|---|
| PARP inhibitors | |||
| BrighTNess
25
Phase 3 NCT02032277 |
A: 316 B: 160
C: 158 |
A: Veliparib + Cp + T → AC
B: Placebo and Cp and T → AC C: Placebo and T → AC. |
A: 53% B: 58% C: 31% |
| Talazoparib
26
Phase 2 NCT02282345 |
17 | 24 weeks Tala
(no neoadjuvant chemotherapy) |
47% a |
| Anthracycline, taxane and platinum combinations | |||
| GeparSepto GBG 69
27
Phase 3 NCT01583426 |
276 | Nab-pac → EC Pac → EC | Nab-pac: 56% Pac: 37% |
| ETNA
28
Phase 3 NCT01822314 |
219 | Nab-pac → AC or EC or FEC Pac → AC
or EC or FEC |
Nab-pac: 41% Pac: 37% |
| WSG-ADAPT-TN
29
Phase 2 NCT01815242 |
336 | Nab-pac and gem Nab-pac and Cp | Nab-pac and gem: 28.7%
Nab-pac and Cp: 45.9% |
| Phase 2
30
NCT01276769 |
91 | T and Cp → surgery → anthracycline
EP → surgery → taxane |
T and Cp: 38.6% EP: 4% |
| GEICAM/2006-03
31
NCT00432172 |
94 | EC-D or EC-D and Cp | EC-D: 30% EC-D & Cp: 30% |
| Cisplatin-1
32
NCT00148694 |
28 | Neoadjuvant cis → surgery → adjuvant
chemotherapy |
22% |
| Phase 1
33
NCT01090128 |
10
(TNBC cohort) |
Nab-pac AC | 100% |
| Chemotherapy backbone with or without novel agents | |||
| PrECOG 0105
34
Phase 2 NCT00813956 |
80 | Gemcitabine, Cp, iniparib | 36% |
| Cisplatin-2
NCT00580333 |
51 | Cis and Bev | 16% |
| CALGB 40603
35
Phase 2 NCT00861705 |
454 | T ± Cp ± bev → ddAC | No Cp: 41% with Cp: 54%
No bev: 52% Bev: 44% Cp and bev: 60% |
| Phase 2
36
NCT00930930 |
145 | Cis + T ± everolimus | Everolimus: 36%
Placebo: 49% |
| Phase 2
37
NCT00600249 |
35 | Cetuximab and D | pCR: 24% |
| GeparQuinto GBG 44
38
Phase 3 NCT00567554 |
663 | EC → D ± bev | With bev: 39.3% No bev:
27.9% |
| Phase 2
39
NCT00933517 |
47 | Panitumumab and FEC-D | 46.8% |
| GeparSixto GBG 66
40
Phase 3 NCT01426880 |
315 (TNBC
cohort) |
T and Liposomal doxorubicin and
Bev ± Cp |
53.2% with Cp
36.9% no Cp |
AC, doxorubicin and cyclophosphamide; Bev, bevacizumab; Cis, cisplatin; Cp, carboplatin; D, docetaxel; ddAC, dose dense doxorubicin and cyclophosphamide; EC, epirubicin and cyclophosphamide; EP, epirubicin and paclitaxel; FEC, 5-fluorouracil and epirubicin and cyclophosphamide; gem, gemcitabine; Nab-pac, nab-paclitaxel; pac, paclitaxel; PARP, poly (ADP-ribose) polymerase; T, paclitaxel; Tala, talazoparib; TNBC, triple-negative breast cancer. aReported as residual cancer burden (RCB) and results represent RCB 0, equivalent to pathological complete response (pCR).