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 6 The clinical trials of PD-1/PD-L1 inhibitors for TNBC

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

Drug name	Com	Name	Num	Regiments	Phase	Status	Object	POM	NCT number
Pembrolizumab (MK-3475, KEYTRUDA®)		KEYNOTE-086	254	200 mg iv on day 1 of q3w for up to 35 cycles	II	Completed	mTNBC	ORR, AEs	NCT02447003
Pembrolizumab		KEYNOTE-012	297	10 mg/kg iv q3w	I	Completed	mTNBC	ORR, AEs	NCT01848834
Pembrolizumab		TAPUR	28	2 mg/kg or 200 mg iv of q3w	II	Recruiting	mTNBC	ORR	NCT02693535
Pembrolizumab		SWOG 1418	1155	Iv over 30 min on days 1 and 22. Cycles repeat every 42 days for 52 weeks	III	Active, not recruiting	TNBC	iDFS	NCT02954874
Pembrolizumab	Chemotherapy (Capecitabine/Eribulin/Gemcitabine/Vinorelbine)	KEYNOTE-119	622	Pembrolizumab: 200 mg iv q3w for up to 35 administrations Chemotherapy: as TPC in accordance with local regulations and guidelines	III	Completed	Advanced or mTNBC	OS	NCT02555657
Pembrolizumab	Chemotherapy (Nab-paclitaxel /Doxorubicin/ Cyclophosphamide)	KEYNOTE-173	60	Pembrolizumab: 200 mg iv q3w Nab-paclitaxel: 125 or 100 mg/m² iv q3w doxorubicin: 60 mg/m² iv q3w Cyclophosphamide: 600 mg/m² q3w	I	Completed	TNBC	DLTs, AEs	NCT02622074
Pembrolizumab	Gemcitabine/carboplatin	KEYNOTE 355	882	Pembrolizumab: 200 mg iv on day 1 of each 21-day cycle Gemcitabine/carboplatin: 1000 mg/m² (gemcitabine) and an AUC 2 (carboplatin) on days 1 and 8 of each 21-day cycle	III	Active, not recruiting	mTNBC	AEs, PFS, OS	NCT02819518
Pembrolizumab	Paclitaxel plus carboplatin	KEYNOTE-522	1174	Pembrolizumab: 200 mg iv q3w Paclitaxel + carboplatin: q3w × 4 cycle Each cycle is 21 days	III	Active, not recruiting	TNBC	pCR, EFS	NCT03036488
Pembrolizumab	Carboplatin and gemcitabine/ olaparib	KEYLYNK-009	460	Pembrolizumab: 200 mg iv on day 1 of each 21-day cycle Carboplatin: AUC 2 with gemcitabine 1000 mg/m² iv on days 1 and 8 of each 21-day cycle Olaparib: 300 mg qd po	II	Active, not recruiting	mTNBC	PFS, OS	NCT04191135
Pembrolizumab	Eribulin	ENHANCE 1	258	Pembrolizumab: 200 mg iv on day 1 of each 21-day cycle Eribulin: 1.4 mg/m² iv on day 1 and 8 of each 21-day cycle	I/II	Completed	Advanced or mTNBC	ORR	NCT02513472
Pembrolizumab	Ladiratuzumab vedotin	SGNLVA-002	211	Pembrolizumab: iv q3w ladiratuzumab vedotin: iv	I/II	Recruiting	Advanced or mTNBC	DLTs, AEs, ORR	NCT03310957
Pembrolizumab	Dinaciclib		32	Pembrolizumab: 200 mg iv on day 1 q3w Dinaciclib: 12 mg/m² day 1 and 8 of a 21 days cycle by 2-h iv	I	Completed	Advanced or metastatic TNBC	MTD, DLTs	NCT01676753
Pembrolizumab	Enobosarm		18	Pembrolizumab: 200 mg iv over 30 min on day 1 Enobosarm: po qd on days 1–21	II	Active, not recruiting	mTNBC	pCR	NCT02971761
pembrolizumab	Imprime	IMPRIME 1	64	Pembrolizumab: 200 mg iv over 30 min on Day 1 of q3w Imprime: 4 mg/kg iv over a 2-h infusion time on days 1, 8 and 15 of q3w treatment cycle	I	Completed	Advanced or mTNBC	ORR	NCT02981303
pembrolizumab	Paclitaxel/ Doxorubicin/ Cyclophosphamide	ISPY-2		Pembrolizumab: 200 mg iv cycles 1,4,7,10 Paclitaxel: 80 mg/m² iv cycles 1–12 Doxorubicin: 60 mg/m² iv every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m² iv every 2 or 3 weeks for 4 cycles	III	Recruiting	Stage II–III TNBC	pCR	NCT01042379
Atezolizumab			661	0.01 mg/kg iv q3w	I	Completed	Advanced or mTNBC	DLTs, MTD	NCT01375842
Atezolizumab		JAVELIN	168	1.0 mg/kg once q2w	I	Completed	Advanced or mTNBC	DLTs	NCT01772004
Atezolizumab	Nab-paclitaxel/ Doxorubicin/ Cyclophosphamide	IMpassion031	333	Atezolizumab: 840 mg iv q2w Nab-paclitaxel: 125 mg/m² iv every week for 12 weeks Doxorubicin: 60 mg/m² iv Cyclophosphamide: 600 mg/m² iv q2w	III	Completed	TNBC	pCR	NCT03197935
Atezolizumab	Nab-paclitaxel	IMpassion130	902	Atezolizumab: 840 mg iv on days 1 and 15 of each 28-day cycle Nab-Paclitaxel: 100 mg/m² iv on days 1, 8, and 15 of each 28-day cycle	III	Completed	Advanced or mTNBC	PFS, OS	NCT02425891
Atezolizumab	Paclitaxel	IMpassion131	653	Atezolizumab: 840 mg iv on days 1 and 15 (± 3 days) of every 28-day cycle Paclitaxel: 90 mg/m² iv on days 1, 8, and 15 of every 28-day cycle	III	Completed	Advanced or mTNBC	PFS	NCT03125902
Atezolizumab	Capecitabine or gemcitabine/carboplatin	IMpassion132	572	Atezolizumab: 1200 mg iv Gemcitabine: 1000 mg/m² on days 1 and 8 of q3w Capecitabine: 1000 mg/m² po bid on days 1 to 14 q3w	III	Recruiting	Advanced or mTNBC	OS	NCT03371017
Atezolizum	Nab-paclitaxel plus cobimetinib +	COLET	169	Atezolizumab: 840 mg iv q2w on days 1 and 15 Paclitaxel: 80 mg/m² iv on day 1, 8, 15 Cobimetinib: 60 mg/d on day 3–23 Each 28-day treatment cycle	II	Completed	Advanced or mTNBC	PFS, ORR	NCT02322814
	Ipatasertib/ Paclitaxel		140	Atezolizumab: 840 mg iv q2w on days 1 and 15 Ipatasertib: 400 mg/d po on days 1–21 Paclitaxel: 80 mg/m² iv on day 1, 8, 15	I	Completed	Advanced or mTNBC	pCR	NCT03800836
Atezolizumab	Paclitaxel /Doxorubicin	IMpassion 030	2300	Atezolizumab: 840 mg iv q2w Paclitaxel: 80 mg/m² qw for 12 weeks Doxorubicin: 60 mg/m² iv q2w	III	Active, not recruiting	Stage II-III TNBC	iDFS	NCT03498716
Atezolizumab	Capecitabine	MIRINAE	284	Atezolizumab: 1200 mg iv q3w Capecitabine: 2500 mg/m²/d day 1–14, q3w for 8 cycles	II	Recruiting	TNBC	iDFS	NCT03756298
Avelumab		A-BRAVE	474	10 mg/kg iv q2w for 1 year	III	Active, not recruiting	TNBC	DFS	NCT02926196
Durvalumab (MEDI4736)	Nab-paclitaxel	GeparNuevo	174	MEDI4736: 1.5 g iv q4w Nab-Paclitaxel 125 mg/m² qw for 12 weeks	II	Completed	TNBC	pCR	NCT02685059
Durvalumab	Olaparib	MEDIOLA	264	Olaparib: bid starting on week 1 day 1 MEDI4736: q4w starting on week 5 day 1	I/II	Active, not recruiting	gBRCA-mBC	safety and tolerability; ORR	NCT02734004
Nivolumab		TONIC	84	Nivolumab: 3 mg/kg q2w	II	Active, not recruiting	Advanced or mTNBC	PFS	NCT02499367
Nivolumab	Pembrolizumab	TOPACIO/KEYNOTE-162	122	Niraparib: 300 mg/d PO on days 1–21 Pembrolizumab: 200 mg iv on day 1 of each 21-day cycle	I/II	Completed	Advanced or mTNBC	DLTs, ORR	NCT02657889
Camrelizumab (SHR-1210)	Apatinib		40	SHR-1210: 3 mg/kg iv q2w Apatinib: 250 mg/d po day 1–14	II	Completed	mTNBC	ORR	NCT03394287

mTNBC: metastatic triple negative breast cancer; TNBC: triple negative breast cancer; HER2-: HER2 negative; mBC: metastatic breast cancer; gBRCA1/2 m: germline BRCA1/2 mutated; ORR: overall response rate; AEs: adverse events; iDFS: invasive disease-free survival; OS: overall survival; DLTs: dose-limiting toxicity; PFS: progression-free survival; EFS: event-free survival; MTD: maximum tolerated dose; pCR: pathologic complete response; DFS: disease-free survival

Back to article page

ISSN: 1756-8722

Contact us

General enquiries: journalsubmissions@springernature.com