Table 2 Phase 1/2 studies of PARPi monotherapy in metastatic breast cancers, with spotlight on BRCA mutated patients
From: PARP inhibitors in the management of breast cancer: current data and future prospects
Study Name (NCT) | Ref. | Phase | Tumor type | No. of patients | Investigation arm | Primary endpoint | Overall results | Results in BRCAm BC | Additional notes |
|---|---|---|---|---|---|---|---|---|---|
[total/BC (BRCAm BC)] | |||||||||
Olaparib | |||||||||
NCT00516373 | [5] | 1 | Solid tumors | 60/9 (3) | Olaparib (10–600 mg bid) | PK, PD, safety and tolerability | ORR: 15 % | ORR 33 % | One CR in BRCAm BC lasting more than 60 weeks |
NCT00572364 | [119] | 1 | Solid tumors | 12/4 (NK) | Olaparib (100–400 mg bid) | Safety and tolerability | ORR: 8 % | – | One patient with BC and family history of BC had PR for 13 months |
NCT00494234 | [34] | 2 | BRCAm BC | 54/54 (54) | C1: olaparib (400 mg bid) | ORR | – | ORR C1: 41 % |  |
C2: olaparib (100 mg bid) | ORR C2: 22 % | ||||||||
NCT00679783 | [7] | 2 | TNBC or BRCAm BC, HGSOC or BRCAm OC | 90/26 (10) | Olaparib (400 mg bid) | ORR | ORR in BC: 0 % | ORR: 0 % | Evidence of activity in non-BRCAm OC and platinum-resistant OC |
ORR in OC: 29 % | 50 % of unconfirmed PR (by RECIST) | ||||||||
NCT01078662 | [6] | 2 | BRCAm solid tumors | 317/62 (62) | Olaparib (400 mg bid) | ORR | ORR: 26 % | ORR: 13 % | Mean number of previous regimens for advanced disease: 4.6 |
DS ≥8 weeks: 47 % | |||||||||
Veliparib | |||||||||
NCT00892736 | [120] | 1 | TNBC, HGSOC and BRCAm BC and OC | 98/35 (14) | Veliparib (50–500 mg) | Tolerability | ORR in BRCAm: 24 % | ORR: 29 % |  |
ORR in BRCA wt: 4 % | CBR: 57 % | ||||||||
Talazoparib | |||||||||
NCT01286987 | [32] | 1 | Solid tumors | 39/8 (6) | Talazoparib (25–1100 μg) | PK, PD, safety and anti-tumor activity | ORR: 65 % in BRCAm OC | ORR: 33 % |  |
Niraparib | |||||||||
NCT00749502 | [31] | 1 | Solid tumors | 100/12 (4) | Niraparib (30–400 mg) | Safety and tolerability | ORR: 18 % in overall population, 40 % in BRCAm OC | ORR: 50 % |  |
Rucaparib | |||||||||
NCT01482715 | 1–2 | BRCAm BC and OC | 56/27 (27) | Rucaparib (18 mg/m2) | ORR | Data mixed between OC and BC, at RP2D ORR: 80 % (4/5) | – |  | |