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Table 1 Clinical trials testing nivolumab in patients with breast cancer

From: Emerging therapies for breast cancer

Disease setting

Phase

Clinical trial reference number

Cancer type

Estimated Enrollment

Primary Endpoint

Regimens

Control arm

Metastatic

II

NCT02892734

HER2-

29

PFS

Nivolumab + ipilimumab

None

Metastatic

I

NCT02309177

HER2-

20

MTD

Nivolumab + nab-paclitaxel

None

Metastatic

II

NCT02499367

TNBC

84

PFS

Nivolumab + doxorubicin/cyclophosphamide/cisplatin/radiation

Active Comparator

Metastatic

I

NCT02453620

HER2-

45

Safety

Nivolumab + entinostat + ipilimumab

None

Metastatic

I/II

NCT01928394

TNBC

58

ORR

Nivolumab ± ipilimumab

None

Metastatic

I

NCT02834247

TNBC

36

MTD/ORR

Nivolumab ± TAK659

None

  1. TNBC, triple negative breast cancer; HER2, human epidermal growth factor receptor-2; PFS, progress free survival; MTD, maximum tolerance dose; ORR, objective response rate