Table 3.

Selected ongoing studies of nab-paclitaxel in all stages of breast cancer

Study, ClinicalTrials.gov identifier	Phase	Planned N	Patient population or stage of disease	Regimen	Primary endpoint
Early-stage (n = 4)
GAIN-2, NCT01690702 [66]	III	2886	High risk, after R0 resection	Adjuvant epirubicin 150 mg/m2 q2w × 3 cycles → nab-P 260-330 mg/m2 × 3 cycles (TBD in run-in-phase) q2w → cyclophosphamide 2000 mg/m2 q2w × 4 cycles	iDFS
				EC q2w → docetaxel q2w
ETNA, NCT01822314	III	632	High risk HER2−	Neoadjuvant nab-P 125 mg/m2 qw 3/4 × 4 cycles → AC, EC, or FEC × 4 cycles	pCR
				Neoadjuvant paclitaxel 90 mg/m2 qw 3/4 × 4 cycles → AC, EC, or FEC × 4 cycles
NCT00618657	II	120	Stage I–III	Neoadjuvant nab-P + carbo + trastuz for HER2+ qw × 12 weeks	PFS
				Neoadjuvant nab-P + carbo qw × 12 cycles + bev q2w × 5 cycles for HER2−
NCT02530489	II	37	TNBC nonmetastatic	Neoadjuvant nab-P 100 mg/m2 + atezolizumab	pCR
NCT02489448	I/II	61	Stage I–III TNBC	Neoadjuvant durvalumab + nab-P qw × 12 cycles → ddAC × 4 cycles	pCR (ypT0/Tis, ypN0)
Metastatic or advanced stage (n = 12)
PERUSE, NCT01572038 [43]	III	1500	HER2+	Trastuz + pertuzumab + taxane of choice	Safety
IMpassion130, NCT02425891	III	350	Untreated locally advanced or metastatic TNBC	nab-P + atezolizumab	PFS
				nab-P + placebo
tnAcity, NCT01881230 [48]	II/III	790	TNBC	Selected nab-P regimen from phase II portion (either nab-P 125 mg/m2 + gem 1000 mg/m2 d1, 8 q3w or nab-P 125 mg/m2 + carbo AUC 2 d1, 8 q3w)	PFS
				Gem 1000 mg/m2 + carbo AUC 2 d1, 8 q3w
SNAP, NCT01746225 [48]	II	258	HER2− MBC	Induction nab-P 125 mg/m2 qw 3/4 × 3 cycles in all patients → randomization into 3 arms: nab-P 150 mg/m2 q2w	ORR by RECIST v1.1
				nab-P 100 mg/m2 qw 3/4
				nab-P 75 mg/m2 qw
NCT00733408	II	63	MBC	Induction nab-P qw 3/4 + bev q2w → maintenance with bev q2w or q3w + erlotinib qd	PFS
NCT01730833	II	50	Stage II–IV HER2+ LABC and MBC	Pertuzumab q3w + trastuz qw + nab-P qw	PFS
NCT01463072	II	40	LABC or MBC in ≥65-year-old patients	nab-P qw 3/4	Tolerability
PembroPlus, NCT02331251	I/II	90	MBC and other solid tumor types	Pembrolizumab + chemotherapy, including nab-P	RP2D
NCT02379247	I/II	54	Locally recurrent BC or MBC	PI3K inhibitor BYL719 + nab-P 100 mg/m2 qw 3/4	Phase I, RP2D; phase II, ORR
NCT01938833	I/II	47	Metastatic inflammatory BC	nab-P + romidepsin qw 3/4	MTD, PFS
STELA, NCT02073916 [46]	I/II	45	HER2+ MBC	T-DM1 + lapatinib + nab-P	MTD
NCT02309177	I	138a	Recurrent MBC and other solid tumor types	Nivolumab + nab-P 100 mg/m2 qw 3/4a	DLTs, safety
				Nivolumab + nab-P 260 mg/m2 q3wa

AC doxorubicin + cyclophosphamide, AUC area under the curve, BC breast cancer, bev bevacizumab, carbo carboplatin, ddAC dose-dense AC, DLT dose-limiting toxicity, EC epirubicin + cyclophosphamide, FEC fluorouracil, epirubicin, and cyclophosphamide, gem gemcitabine, HER2 human epidermal growth factor receptor 2, iDFS invasive disease-free survival, is in situ, LABC locally advanced breast cancer, MBC metastatic breast cancer, MTD maximum tolerated dose, nab-P nab-paclitaxel, ORR overall response rate, pCR pathologic complete response, PD-L1 programmed death-ligand 1, PFS progression-free survival, PI3K phosphoinositide 3-kinase, q2w every 2 weeks, q3w every 3 weeks, qd daily, qw weekly, qw 3/4 first 3 of 4 weeks, R resection margin, RECIST Response Evaluation Criteria In Solid Tumors, RP2D recommended phase 2 dose, T primary tumor, TBD to be determined, T-DM1 trastuzumab emtansine, TNBC triple-negative breast cancer, trastuz trastuzumab, yp postneoadjuvant therapy

^aPertains to MBC arms only