Table 1.
Ongoing Trials Testing PARP-Inhibitors in Combination With Immune Checkpoint Blockade in Breast Cancer
| Reference | Drug(s) | Phase | Breast cancer subtype | Selection (HRD or BRCA status or others) | Status |
|---|---|---|---|---|---|
| NCT02657889 (TOPACIO) | Niraparib and pembrolizumab | I/II | TNBC | Selection will not be restricted based on these variables | Active, not recruiting |
| NCT03307785 | Niraparib, TSR-022 (anti-TIM3), bevacizumab, and platinum based-doublet chemotherapy plus TSR-042 (anti-PD-1) | I | Advanced solid tumors | Selection will not be restricted based on these variables | Recruiting |
| NCT03565991 | Talazoparib and avelumab | II | Locally advanced or metastatic solid tumors with a BRCA or ATM defect | BRCA or ATM gene defect | Recruiting |
| NCT03330405 | Talazoparib and avelumab | I/II | TNBC; HR + BC DDR Defect + Assay | BRCA or ATM gene defect | Recruiting |
| NCT03061188 | Veliparib and nivolumab | I/Ib | Advanced solid tumors | Genomically profiled tumors (BRCA1 pathway, Fanconi's proteins pathway, and RAD51 pathway) | Recruiting |
| NCT02734004 (MEDIOLA) | Olaparib and durvalumab | I/II | BRCAm HER2-negative BC | Cohorts distinguished based on gBRCA; mBRCA, HRD | Recruiting |
| NCT03842228 | Olaparib, durvalumab, and copanlisib (PI3K-inhibitor) | I | Advanced solid tumors | Molecularly selected solid tumors: germline or somatic mutations of DDR genes (BRCA1/2, RAD51 B/C/D, PALB2, etc) | Not yet recruiting |
| NCT03544125 | Olaparib and durvalumab | I | TNBC | Molecular profiling will be performed in pretreatment biopsies | Recruiting |
| NCT03167619 (DORA) | Olaparib and durvalumab | II | TNBC | Selection was not restricted based on these variables | Recruiting |
| NCT02849496 | Olapariband atezolizumab | II | Non-HER2-positive BC | HRD | Recruiting |
| NCT03594396 | Olaparib and durvalumab | I/II | TNBC or Low ER+ | Selection was not restricted based on these variables | Recruiting |
| NCT02484404 | Olaparib, cediranib and durvalumab | I/II | TNBC | gBRCAm | Recruiting |
| NCT03801369 | Olaparib and durvalumab | II | TNBC | Patients with gBRCAm TNBC will be excluded | Recruiting |
| NCT03740893 | Olaparib, durvalumab, AZD6738 | II | TNBC | Selection was not restricted based on these variables | Not yet recruiting |
| NCT03772561 | Olaparib and durvalumab, AZD5363 (MEDIPAC) |
I | Advanced or metastatic solid tumor malignancies | NA | Recruiting |
| NCT01042379 | Olaparib and durvalumab | II | Breast cancer | Selection will be done based on biomarker signature | Recruiting |
| NCT03101280 | Rucaparib and atezolizumab | I | TNBC | tBRCA mutation [tBCRA(mut)] or BRCA-like molecular signature [tBRCA (wt)/LOH(high)] | Recruiting |
TNBC = triple-negative breast cancer; PARP = poly (ADP-ribose) polymerase; NA = not applicable.