Table 2.
Immune checkpoint inhibitor trials for breast cancer in the recruitment phase
| Agent | Trial / Phase | Setting |
|---|---|---|
| Pembrolizumab | Breast Cancer Study of Preoperative Pembrolizumab + Radiation / Phase 1 | Neoadjuvant |
| A Study of Changes in PD-L1 Expression during Preoperative Treatment with Nab-Paclitaxel and Pembrolizumab in Hormone Receptor-Positive Breast Cancer / Phase 1 | Neoadjuvant | |
| Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple-Negative Breast Cancer / Phase 1 | Neoadjuvant | |
| Study of Immunotherapy in Combination with Chemotherapy in HER2-Negative Inflammatory Breast Cancer / Phase 2 | Neoadjuvant | |
| Neoadjuvant Phase 2 Study of Pembrolizumab and Carboplatin plus Docetaxel in Triple-Negative Breast Cancer / Phase 2 | Neoadjuvant | |
| Neoadjuvant Her2-Targeted Therapy and Immunotherapy with Pembrolizumab / Phase 2 | Neoadjuvant | |
| Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca / Phase 2 | Neoadjuvant | |
| I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer / Phase 2 | Neoadjuvant | |
| Pembrolizumab in High-Risk Ductal Carcinoma in situ (DCIS) / Phase 1 | Neoadjuvant | |
| Study of Pembrolizumab (MK-3475) versus Placebo in Combination with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2–) Breast Cancer (MK-3475-756/KEYNOTE-756) / Phase 3 | Neoadjuvant/ adjuvant | |
| Pembrolizumab in Treating Patients with Hormone Receptor-Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy / Phase 2 | Adjuvant | |
| Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer / Phase 3 | Adjuvant | |
| Pembrolizumab with Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients with Chest Wall Disease / Phase 2 | Adjuvant/ metastatic | |
| Study of GX-I7 in Combination with Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899) / Phases 1 and 2 | Adjuvant/ metastatic | |
| Pembrolizumab in Treating Patients with Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy / Phase 2 | Adjuvant/ metastatic | |
| Galinpepimut-S in Combination with Pembrolizumab in Patients with Selected Advanced Cancers / Phases 1 and 2 | Adjuvant/ metastatic | |
| Nivolumab | Peri-Operative Ipilimumab+Nivolumab and Cryoablation versus Standard Care in Women with Triple-Negative Breast Cancer / Phase 2 | Neoadjuvant |
| Trial of Nivolumab with Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC) / Phase 2 | Neoadjuvant | |
| A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men with Primary Breast Cancer / Phase 2 | Neoadjuvant | |
| Ipilimumab, Nivolumab, and Talimogene Laherparepvec before Surgery in Treating Participants with Localized, Triple-Negative or Estrogen Receptor-Positive, HER2-Negative Breast Cancer-Deleted / Phase 1 | Neoadjuvant | |
| Study of Nivolumab versus Placebo in Participants with High-Risk Breast Cancer / Phase 3 | Neoadjuvant/ adjuvant | |
| OXEL: Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for TNBC with Residual Disease / Phase 2 | Adjuvant | |
| TPST-1120 as Monotherapy and in Combination with (Nivolumab, Docetaxel or Cetuximab) in Subjects with Advanced Cancers / Phase 1 | Adjuvant/ metastatic | |
| COM701 in Subjects with Advanced Solid Tumors / Phase 1 | Adjuvant/ metastatic | |
| Nivolumab and Ipilimumab in Treating Patients with Rare Tumors / Phase 2 | Adjuvant/ metastatic | |
| FT500 as Monotherapy and in Combination with Immune Checkpoint Inhibitors in Subjects with Advanced Solid Tumors / Phase 1 | Adjuvant/ metastatic | |
| Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (the MATCH Screening Trial) / Phase 2 | Adjuvant/ metastatic | |
| Atezolizumab | Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed after Surgery by Atezolizumab or Placebo / Phase 3 | Neoadjuvant |
| A Study to Evaluate the Efficacy and Safety of Atezolizumab or Placebo in Combination with Neoadjuvant Doxorubicin + Cyclophosphamide Followed by Paclitaxel + Trastuzumab + Pertuzumab in Early Her2-Positive Breast Cancer / Phase 3 | Neoadjuvant | |
| Neoadjuvant Treatment of HER2-Positive Early High-Risk and Locally Advanced Breast Cancer / Phase 3 | Neoadjuvant | |
| Nab-Paclitaxel and Atezolizumab before Surgery in Treating Patients with Triple-Negative Breast Cancer / Phase 2 | Neoadjuvant | |
| Pre-Operative Immunotherapy Combination Strategies in Breast Cancer / Phase 2 | Neoadjuvant | |
| Improving Pre-Operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2)-Amplified Breast Cancer / Phase II | Neoadjuvant | |
| A Window-of-Opportunity Study of Pelareorep in Early Breast Cancer / Phase 1 | Neoadjuvant | |
| A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients with Newly Diagnosed Breast Cancer in Latin America | Neoadjuvant | |
| M7824 in Treating Patients with Stage II-III HER2-Positive Breast Cancer / Phase 1 | Neoadjuvant | |
| Combination of Talimogene Laherparepvec with Atezolizumab in Early Breast Cancer / Phase 1 | Adjuvant | |
| A Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination with Adjuvant Anthracycline/ Taxane-Based Chemotherapy versus Chemotherapy Alone in Patients with Operable Triple-Negative Breast Cancer / Phase 3 | Adjuvant | |
| Efficacy and Safety of Atezolizumab plus Capecitabine Adjuvant Therapy for Triple Receptor-Negative Breast Cancer / Phase 2 | Adjuvant | |
| PRS-343 in Combination with Atezolizumab in HER2-Positive Solid Tumors / Phase 1 | Adjuvant/ metastatic | |
| Durvalumab | Durvalumab with Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer / Phase 2 | Neoadjuvant |
| Safety and Efficacy of Durvalumab Combined to Neoadjuvant Chemotherapy in Localized Luminal B HER2(–) and Triple-Negative Breast Cancer / Phases 1 and 2 | Neoadjuvant | |
| Neoadjuvant MEDI4736 Concomitant with Weekly Nab-Paclitaxel and Dose-Dense AC for Stage I-III Triple-Negative Breast Cancer / Phases 1 and 2 | Neoadjuvant | |
| Window-of-Opportunity Trial of Neoadjuvant Olaparib and Durvalumab for Triple-Negative or Low ER+ Breast Cancer / Phases 1 and 2 | Neoadjuvant | |
| Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer / Phase 2 | Neoadjuvant | |
| Neo-Adjuvant Chemotherapy Combined with Stereotactic Body Radiotherapy to the Primary Tumour +/– Durvalumab, +/– Oleclumab in Luminal B Breast Cancer / Phase 2 | Neoadjuvant | |
| PHOENIX DDR/Anti-PD-L1 Trial: A Pre-Surgical Window-of-Opportunity and Post-Surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition and/or Anti-PD-L1 Immunotherapy in Patients with Neoadjuvant Chemotherapy-Resistant Residual Triple-Negative Breast Cancer / Phase 2 | Neoadjuvant | |
| I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer / Phase 2 | Neoadjuvant | |
| Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine plus Durvalumab in Triple-Negative Breast Cancer Patients following Standard of Care Therapy / Phase 1 | Adjuvant | |
| Ascending Doses of Ceralasertib in Combination with Chemotherapy and/or Novel Anti-Cancer Agents / Phases 1 and 2 | Adjuvant/ metastatic | |