Recent advances in targeted strategies for triple-negative breast cancer

Zhu, Shuangli; Wu, Yuze; Song, Bin; Yi, Ming; Yan, Yuheng; Mei, Qi; Wu, Kongming

doi:10.1186/s13045-023-01497-3

Journal of Hematology & Oncology

Table 3 The clinical trials of CDK inhibitors in TNBC

From: Recent advances in targeted strategies for triple-negative breast cancer

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

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ISSN: 1756-8722

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