Trial (NCT identifier) | Design | PARPi | Adjuvant therapy | Biomarker status | Primary endpoints | Estimated enrollment | Status |
Upfront: neoadjuvant | |||||||
NOW (NCT03943173) | Monocenter, single-arm, phase I | Olaparib 300 mg orally twice daily for two 28-day cycles | Either surgery → CHT for up to four cycles or NACT for up to four cycles → surgery, followed by olaparib, at the physician’s discretion | BRCA-mutated | Feasibility | 17 | Recruiting |
OLAPem (NCT04417192) | Multicenter, single-arm, phase II | Olaparib 300 mg orally twice daily for two 21-day cycles ± pembrolizumab | NR | HRD | ORR | 30 | Active, not recruiting |
NUVOLA (NCT04261465) | Multicenter, single-arm, phase II | Olaparib 300 mg orally twice daily for three consecutive days (D1-D3), every week for each cycle plus weekly carboplatin and paclitaxel for three cycles | Carboplatin and paclitaxel | BRCA-mutated | Pathological complete response | 35 | Unknown |
IMPACT (NCT03378297) | Monocenter, single-arm, phase I, randomized window-of-opportunity study | Olaparib for 10–14 days | NR | NR | Changes in the expression of biomarkers | Olaparib: 32 Control: 16 | Completed |
NANT (NCT04507841) | Multicenter, single-arm, phase II | Niraparib 100–300 mg once daily | NR | HRD | ORR, R0 resection rate | 53 | Recruiting |
OPAL-C (NCT03574779) | Multicenter, phase II, multicohort umbrella, randomized | Niraparib 100–300 mg once daily for three 21-day cycles vs standard of care plus one run-in cycle of carboplatin-paclitaxel during pre-screening | Up to three 21-day cycles of platinum-taxane doublet ± bevacizumab followed by niraparib ± bevacizumab | HRD | ORR | 125 | Recruiting |
Upfront: adjuvant | |||||||
N-PLUS (NCT05460000) | Multicenter, phase III, randomized (1:1) | Niraparib 100–300 mg once daily following PDS with R0 | Six cycles vs three cycles of carboplatin and paclitaxel | HRD | RFS | 640 | Recruiting |
Recurrence (platinum-eligible) | |||||||
NEO (NCT02489006) | Multicenter, phase II, randomized | Olaparib 300 mg orally twice daily for six weeks (± two weeks) prior to surgery | Olaparib, 300 mg orally twice daily ± standard chemotherapy | All-comers | Difference in levels of PAR or PARP-1 before and after olaparib. Mutations in HR genes in germline tissue compared with tumor tissue. | 71 | Active, not recruiting |
BRCA, BReast CAncer genes; CHT, chemotherapy; HR, homologous recombination; HRD, homologous recombination deficiency; NACT, neoadjuvant chemotherapy; NCT, National Clinical Trial identifier number; NR, not reported; ORR, overall response rate; PAR, poly(ADP-ribose); PARPi, poly(ADP-ribose) polymerase inhibitors; PDS, primary debulking surgery; R0, no gross residual tumor after surgery; RFS, recurrence-free survival.