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Table 3 Selected ongoing studies of nab-paclitaxel in all stages of breast cancer

From: nab-Paclitaxel for the treatment of breast cancer: an update across treatment settings

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

  1. 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
  2. aPertains to MBC arms only
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Experimental Hematology & Oncology

ISSN: 2162-3619

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