Table 2 Ongoing clinical trials of endocrine therapy combined with immune checkpoint inhibitors therapies for breast cancer
From: The immunomodulatory effects of endocrine therapy in breast cancer
Treatment arms | Clinicaltrials.gov identifier | Phase | Patient and enrollment criteria | Primary Outcome Measures | Secondary Outcome Measures | Completion Date |
|---|---|---|---|---|---|---|
Pembrolizumab + Tamoxifen | NCT03879174 | 2 | Advanced hormone receptor- positive breast cancer and ESR1 mutation | PFS, ORR | OS | August 1, 2022 |
Pembrolizumab + Fulvestrant | NCT03393845 | 2 | Hormone receptor-positive, HER2-negative advanced/metastatic breast cancer | ORR | Safety profile | January 1, 2022 |
Pembrolizumab + Exemestane + Leuprolide | NCT02990845 | 1/2 | Premenopausal hormone receptor positive/HER2 negative locally advanced or metastatic breast cancer | PFS | AEs, ORR, CBR, DOR | December 2021 |
Durvalumab + Aromatase Inhibitor (Anastrozole/Letrozole/Exemestane) | NCT03874325 | 2 | Hormone receptor positive breast cancer | Rate of modified preoperative endocrine prognostic index (mPEPI) score of 0 | CR, PR, PD, SD | March 11, 2025 |
Atezolizumab + Fulvestrant, Atezolizumab + Ipatasertib, Atezolizumab + Ipatasertib + Fulvestrant | NCT03280563 | 1/2 | Hormone receptor positive, human epidermal growth factor receptor 2-negative breast cancer | OR | PFS, CBR, OS, DR, AEs | October 5, 2022 |
Pembrolizumab + Letrozole + Palbociclib | NCT02778685 | 2 | Estrogen receptor positive, HER2/neu negative, postmenopausal metastatic breast carcinoma, stage IV breast cancer | CR, PR | CRR, DOR, AEs, OS, PFS, TTF | September 2020a |
Fulvestrant + Palbociclib + Avelumab | NCT03147287 | 2 | Metastatic hormone receptor positive, HER2 negative breast cancer | PFS | ORR, AEs | December 31, 2024 |
Abemaciclib + Pembrolizumab, Abemaciclib + Pembrolizumab + Anastrozole | NCT02779751 | 1b | Hormone receptor-positive, HER2-negative breast cancer | SAEs, AEs | ORR, DCR, DOR, PFS, OS, PK | October 29, 2021 |
Abemaciclib + Durvalumab + Aromatase inhibitor (exemestane/anastrozole/ letrozole) | NCT04088032 | 1 | Locally advanced hormone receptor-positive breast cancer | AEs | Pathologic response at surgery | December 31, 2020 |
Nivolumab + Palbociclib + Anastrozole | NCT04075604 | 2 | Hormone receptor positive, HER2-negative breast cancer | DLT, RCB, | AEs, SAE, laboratory abnormalities, pCR, ORR, BCS rate | March 9, 2022 |