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. 2023 Aug 28;16:100. doi: 10.1186/s13045-023-01497-3

Table 1.

The clinical trials of PARP inhibitors in TNBC

Drug name Com Num Trial Name Regiment Phase Status Object POM NCT number
Olaparib (AZD2281) 1836 OlympiA 300 mg bid po III Active, not recruiting Early-stage gBRCA, adjuvant therapy iDFS NCT02032823
Olaparib 99

400 mg bid po (capsules)

Or 300 mg bid po (tablets)

 II Completed Advanced TNBC ORR NCT00679783
Olaparib 54 100 mg/400 mg bid II Completed gBRCA1/2 m and advanced TNBC ORR NCT00494234
Olaparib 30 300 mg bid for 4 weeks of each cycle II Not yet recruiting mTNBC ORR NCT05522491
Olaparib Ceralasertib/ Adavosertib 273 VIOLETTE

Olaparib: 300 mg bid 28-day cycle

Ceralasertib: 160 mg/d

Adavosertib: 150 mg bid

 II Active, not recruiting mTNBC PFS NCT03330847
Olaparib Cediranib 155

Olaparib: 100–400 mg po bid on days 1–28

Cediranib: po

 I/II Active, not recruiting mTNBC PFS NCT01116648
Olaparib Durvalumab 45 DORA

Olaparib: 300 mg bid

Durvalumab: iv every 28 days

 II Completed Advanced TNBC PFS NCT03167619
Olaparib Durvalumab (MEDI4736) 264 MEDIOLA

Olaparib: 300 mg bid for 4 weeks

Durvalumab: q4w starting on day 1

 I/II Active, not recruiting gBRCAm HER2-mBC/TNBC PFS NCT02734004
Olaparib Durvalumab 3

Olaparib: po bid for 28 days

Durvalumab: iv over 1 h on day 1

 I Completed mTNBC CLIA NCT03544125
Olaparib Durvalumab 132

Olaparib: po bid on days 1–28

Durvalumab: iv over 1 h on day 1

 II Recruiting mTNBC ORR NCT03801369
Olaparib Physician's choice chemotherapy 302 OlympiAD

Olaparib: 300 mg bid po

Capecitabine: 2500 mg/m2 day 1-14

or Vinorelbine 30 mg/m2 day 1,8

or Eribulin 1.4 mg/m2 day 1,8

 III Active, not recruiting Advanced/Metastatic gBRCA, ≤ 2 prior lines PFS NCT02000622
Olaparib Paclitaxel 19

Olaparib: 200 mg bid

Paclitaxel: iv over 1 h

 I/II Completed mTNBC AEs NCT00707707
Olaparib Radiation therapy 24

Olaparib: five levels of dose, po bid each day

IMRT

 I Unknown Advanced or mTNBC MTD NCT03109080

Veliparib

(ABT-888)

 Temozolomide 294

Veliparib: 40 mg bid days 1–7

Temozolomide: 150 to 200 mg/m2 qd days 1–5 in each 28-day cycle

 II Completed Metastatic gBRCA, ≤ 0–2 prior lines PFS NCT01506609
Veliparib Carboplatin and Paclitaxel 294

Veliparib: 80 mg bid day 1–7

Carboplatin: day 3 of each 21-day cycle

Paclitaxel: 175 mg/m2 on day 3 of each 21-day cycle

 II Completed Metastatic gBRCA, ≤ 0–2 prior lines PFS NCT01506609
Veliparib Carboplatin and Paclitaxel 509 BROCADE3

Veliparib: 120 mg bid on day 2–5 of a 21-day cycle

Carboplatin: iv AUC 6 mg/ml/min on day 1 of every cycle

Paclitaxel: 80 mg/m2 iv on day 1, 8, and 15 of every cycle

 III Active, not recruiting Metastatic or advanced gBRCA1/2 m HER2- BC/TNBC mPFS NCT02163694
Veliparib Carboplatin and Paclitaxel 634 BrighTNess

Veliparib: 50 mg po bid

Paclitaxel: 80 mg/m2 iv weekly for 12 doses

Carboplatin: AUC 6 mg/mL/min iv q3w for 4 cycles

 II Completed Stage II or III TNBC Neoadjuvant pCR NCT02032277
Veliparib Carboplatin and Paclitaxel 116 I-SPY 2 NA II Recruiting Stage II or III TNBC Neoadjuvant pCR NCT01042379
Veliparib Cyclophosphamide 124

Veliparib: 60 mg po by mouth

Cyclophosphamide: 50 mg po by mouth for 21d

 II Completed Advanced TNBC ORR, PFS NCT01306032

Talazoparib

(BMN 673)

 431 EMBRACA 1.0 mg/d po for 21 continuous days III Completed Advanced/Metastatic gBRCA, ≤ 3 prior lines PFS NCT01945775
Talazoparib 84 ABRAZO 1 mg qd II Terminated gBRCA1/2 m advanced TNBC ORR NCT02034916
Talazoparib 36 1 mg/d po for 6 months II Completed gBRCA1/2 m and operable HER2- BC/TNBC pCR NCT02282345
Niraparib 216 BRAVO 300 mg (3 × 100 mg capsules) /d po for 21 continuous days III Terminated Advanced/Metastatic gBRCA, ≤ 2 prior lines PFS NCT01905592
Niraparib Pembrolizumab 122 TOPACIO

Niraparib: 300 mg/d po on Day 1-21

Pembrolizumab: 200 mg iv on Day 1 of each 21-day cycle

 I/II Completed Advanced TNBC DLTs, ORR NCT02657889

iDFS: invasive disease-free survival; mTNBC: metastatic triple negative breast cancer; HER2-: HER2 negative; mBC: metastatic breast cancer; gBRCA1/2 m: germline BRCA1/2 mutated; ORR: overall response rate; PFS: progression-free survival; CLIA: Clinical Laboratory Improvement Act; AEs: adverse events; IMRT: intensity modulated radiotherapy; MTD: maximum tolerated dose; DLTs: dose-limiting toxicity; Com: Combination; Num: Number; POM: Primary outcome measures