Table 3.
Selected PARP inhibitor trials in sporadic breast cancers.
| Trial | Study population | PARP inhibitor | Comparison therapy | Clinical responsesa |
|---|---|---|---|---|
| Phase II | Recur, advanced BRCAutmut OC (N = 17)/BCs (N = 10), or BRCAtwt HGS, and/or undifferentiated OC (N = 47)/TNBC (N = 16) | Olaparib | None | BRCAtwt TNBC |
| Gelmon et al. (65) | CR + PR: 0/15 | |||
| NCT00679783 | SD: 2/15 | |||
| Phase I | Refractory or recur BC (N = 4) and OC | Olaparib + carboplatin | None | BC |
| Lee et al. (99) | PR: 3/4 | |||
| NCT01237067 | SD: 1/4 | |||
| Phase I | Advanced solid tumors N = 87, including BC (26%) and OC (7%), of which 12 BRCAutmut | Olaparib + carboplatin ± paclitaxel | None | ORR: 14/87 (16%)b |
| van der Noll et al. (90) | CR: 5% | |||
| NCT00516724 | PR: 11% | |||
| SD: 28% | ||||
| Phase I | Recur or advanced EOC/TNBC | Olaparib + cediranib (angiogenesis inhibitor) | None | BC |
| Liu et al. (82) | N = 28, of which 8 BC | ORR: 0/7 | ||
| NCT01116648 | SD: 2/7 | |||
| Phase I | Advanced solid tumors | Olaparib + cisplatin | None | CR: 1/54b |
| Balmana et al. (100) | N = 54, of which 42 BC | PR: 17/54b | ||
| NCT00782574 | SD: 23/54b | |||
| Phase I | Met TNBC | Olaparib + paclitaxel | None | PR: 7/19 |
| Dent et al. (76) | N = 19 | SD: 1/19 | ||
| NCT00707707 | ||||
| Phase I | Advanced BRCAutmut solid tumors, or BRCAtwt tumors (N = 25, of which 21 BLBC) | Veliparib | None | BRCAtwt BLBC |
| Huggins-Puhalla et al. (91) | PR: 1/21 | |||
| NCT00892736 | BRCAtwt | |||
| SD: 7/25b | ||||
| Phase I | Refractory solid tumors/lymphoma | Veliparib | Cyclophosphamide | PR: 7/35b |
| Kummar et al. (101) | N = 35, including BC and OC | SD: 6/35b | ||
| NCT00810966 | ||||
| Phase I Ramaswamy et al. (92) NCT01251874 | Met or unresect BRCAutmut BC, or BRCAtwt TNBC and other BCs | Veliparib + carboplatin | None | PR: 8/38 SD: 17/38 |
| N = 38, of which 6 BRCAutmut and 7 FAefdef | ||||
| FAefdef | ||||
| PR: 2/7 | ||||
| SD: 5/7 | ||||
| Phase I | Met or unresect solid tumors | Veliparib + carboplatin and gemcitabine | None | CR: 2/59b |
| Bell-McGuinn et al. (98) | N = 59, of which 10 BC | PR: 11/59b | ||
| NCT01063816 | Of 13 responses, 8 BRCAutmut OC, 3 other OC, 2 others | |||
| Phase I | Advanced solid tumors including BC | Veliparib + carboplatin and paclitaxel | None | BC |
| Appleman et al. (102) | N = 68, of which 14 BC | CR: 3/14 | ||
| NCT00535119 | PR: 5/14 | |||
| Phase I | Met or unresect solid tumors, including BC (Q1 week, N = 10 TNBC, Q3 week, N = 9 TNBC) | Veliparib + carboplatin and paclitaxel | None | TNBC |
| Puhalla et al. (80) NCT01281150 | (Q1 week), CR: 2/10, PR: 3/10, SD: 3/10 | |||
| (Q3 week), CR: 3/9, PR: 4/9, SD: 1/9 | ||||
| Phase I Rodler et al. (94) NCT01104259 | Met BRCAutmut BC or recur and/or met BRCAtwt TNBC | Veliparib + cisplatin and vinorelbine | None | PR: 6/11b SD: 5/11b |
| N = 18, of which 5 BRCA1/2utmut | ||||
| Phase I Tan et al. (95) NCT00740805 | Met BC | Veliparib + cyclophosphamide and doxorubicin | None | PR: 2/11 (both BRCA2utmut) |
| N = 11, of which 3 BRCA2utmut | SD: 6/11 (of which 1 BRCA2utmut) |
aData include only patients with measurable disease.
bCollective data reported.
recur, recurrent; BRCAmut, mutated BRCA; OC, ovarian cancer; BC, breast cancer; BRCAwt, BRCA-wild type; HGS, high-grade serous; TNBC, triple negative breast cancer; CR, complete response; PR, partial response; SD, stable disease; ORR, objective response rate; EOC, epithelial ovarian cancer; met, metastatic; BLBC, basal-like breast cancer; FAdef, fanconi anemia pathway deficiency.