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Table 3 Clinical trials testing the association of checkpoint inhibitors and HER2-targeted treatment in HER2 + BC

From: Interaction of host immunity with HER2-targeted treatment and tumor heterogeneity in HER2-positive breast cancer

Study

Phase

Setting

Treatment

N. Patients

Primary outcome evaluated

NCT02605915 Cohort 2A

Ib

Neoadjuvant

HER2+ BC

Atezolizumab/Trastuzumab/Pertuzumab followed by docetaxel + carboplatin + trastuzumab + pertuzumab

98 entire trial (recruiting)

Safety

NCT02605915 Cohort 2B

Ib

Neoadjuvant

HER2+ BC

Atezolizumab + T-DM1 followed by docetaxel + carboplatin + trastuzumab + pertuzumab

NCT02605915 Cohort 1A

Ib

locally advanced or mHER2+ BC

Atezolizumab/Trastuzumab/Pertuzumab

NCT02605915 Cohort 1B-C-D

Ib

locally advanced or mHER2+ BC

Atezolizumab + T-DM1

NCT02605915 Cohort 1F

Ib

locally advanced or mHER2 + BC

Atezolizumab/Trastuzumab/Pertuzumab/ Docetaxel

NCT03032107

I

mHER2+ BC

T-DM1 + Pembrolizumab

27 (recruiting)

Safety

NCT02649686

Ib

mHER2+ BC

Trastuzumab + Durvalumab

15 (active, not recruiting)

Safety

NCT03272334

I/II

mHER2 + BC

Pembrolizumab + Anti-CD3 x Anti-HER2 Armed Activated T Cells

33 (recruiting)

Safety

NCT02129556 (PANACEA)

Ib/II

Unresectable or mHER2+ BC

Pembrolizumab + Trastuzumab

58 (active, not recruiting)

Phase I: Safety

Phase II: Response by RECIST

NCT03417544

II

mHER2+ BC with brain mts

Atezolizumab + trastuzumab + pertuzumab

33 (recruiting)

Overall Response Rate by RANO-BM criteria

NCT03125928

II

Unresectable or mHER2+ BC

Atezolizumab + paclitaxel + trastuzumab + pertuzumab

50 (recruiting)

Safety and Response by RECIST

NCT03414658

II

mHER2 + BC progressed to prior trastuzumab and pertuzumab

Randomized:

-Trastuzumab/Vinorelbine

-Trastuzumab/Vinorelbine+Avelumab

- Trastuzumab/Vinorelbine+Avelumab +Utomilumab

100 (recruiting)

PFS

NCT03199885

III

mHER2 + BC

Randomized:

-Paclitaxel/Trastuzumab/Pertuzumab + Pembrolizumab

-Paclitaxel/Trastuzumab/Pertuzumab

480 (not yet recruiting)

PFS

  1. BC breast cancer, mBC metastatic breast cancer, N number, PFS progression-free survival, RANO-BM response assessment in neuro-oncology – brain metastases