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 1 The clinical trials of PARP inhibitors in TNBC

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

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

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