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

Table 3.

The clinical trials of CDK inhibitors in TNBC

Drug name Com Num Regiments Ph State Object POM NCT number
Palbociclib Binimetinib 24

Palbociclib: 100 mg/d po, 21 days on/7 days off

Binimetinib: 45 mg bid po, 21 days on/7 days off

 I/II Active, not recruiting mTNBC PFS NCT04494958
Palbociclib Paclitaxel/ carboplatin 126

Palbociclib: 125 mg/d po on days 1–14

Paclitaxel: 80 mg/m2 iv on day 1, 8, 15 and 22

Carboplatin: AUC 2 iv on day 1, 8, 15 and 22

 II Not yet recruiting TNBC Early metabolic response NCT05067530
Palbociclib Avelumab 45 NA I Recruiting AR+TNBC MTD NCT04360941
Trilaciclib Gemcitabine/ Carboplatin 102

Trilaciclib: 240 mg/m2 iv on day 1, 8

Gemcitabine: 1000 mg/m2 on day 1, 8

Carboplatin: AUC 2 on day 1, 8 of each 21-cycle

 II Terminated mTNBC DSN NCT02978716
Trilaciclib Gemcitabine/ Carboplatin 194

Trilaciclib: 240 mg/m2 iv on day 1, 8

Gemcitabine: 1000 mg/m2 on day 1, 8

Carboplatin: AUC 2 on day 1, 8 of each 21-cycle

 III Active, not recruiting mTNBC OS NCT04799249
Trilaciclib Sacituzumab Govitecan 30 Trilaciclib: 240 mg/m2 iv on day 1, 8 Sacituzumab Govitecan: 10 mg/kg II Active, not recruiting TNBC PFS NCT05113966
Trilaciclib Doxorubicin/ Cyclophosphamide/ Pembrolizumab 24

Trilaciclib: 240 mg/m2

Doxorubicin: 60 mg/m2 q2w for the first 4 cycles

Cyclophosphamide: 600 mg/m2 for cycles 5–16 Pembrolizumab: 400 mg iv q6w for cycles 1, 4, 9, 15

 II Completed TNBC pCR NCT05112536
Trilaciclib Epirubicin/ Cyclophosphamide/ Pembrolizumab 150

Trilaciclib: 240 mg/m2 iv on day 1

Epirubicin: 100 mg/m2 iv on day 1, q2w/q3w

Cyclophosphamide:600 mg/m2 on day 1, q2w/q3w

Paclitaxel:100 mg/m2 iv on day 1,8,15, q3w, 4 cycles

 II Not yet recruiting TNBC The incidence of CIN NCT05862610
Etoposide Anlotinib 100 Etoposide: 75 mg/d po on day 1-10, 21 days/cycle Anlotinib: 12 mg/d po on day 1-14, 21 days/cycle II Recruiting Advanced TNBC ORR NCT04452370
Abemaciclib Surgery 200

Abemaciclib: PO BID on days 1–14 or days 1–21

Surgery: no later than 12 weeks after the last dose of neoadjuvant chemotherapy

 II Recruiting Refractory TNBC Incidence of AEs NCT03979508
Prexasertib 111 105 mg/m2 iv once every 14 days, 28 days/cycle II Terminated TNBC Objective Response NCT02203513
Prexasertib LY3023414 10

Prexasertib: 80 mg/m2 iv q2w

LY3023414: 150 mg bid

 II Active, not recruiting mTNBC ORR NCT04032080

mTNBC: metastatic triple negative breast cancer; PFS: progression-free survival; AUC: area under the curve; AR+TNBC: androgen receptor-positive triple negative breast cancer; MTD: maximum tolerated dose; DSN: duration of Severe (Grade 4) Neutropenia; OS: overall survival; pCR: pathologic complete response; ORR: overall response rate; AEs: adverse events; NA: not acquire