| Trials with PD-1/PD-L1 inhibitors and chemotherapy |
| PHOENIX DDR/Anti-PD-L1 Trial |
Durvalumab |
TNBC |
Window of opportunity |
NCT03740893 |
| Safety and Efficacy of Durvalumab Combined to Neoadjuvant Chemotherapy in Localised Luminal B HER2(-) and Triple-Negative Breast Cancer (B-IMMUNE) |
Durvalumab |
HR-positive, HER2-negative |
Phase Ib/II, open label |
NCT03356860 |
| Neoadjuvant MEDI4736 Concomitant With Weekly Nab-paclitaxel and Dose-dense AC for Stage I-III Triple-Negative Breast Cancer |
Durvalumab |
TNBC |
Phase I/II, single arm |
NCT02489448 |
| Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer (PELICAN) |
Pembrolizumab |
HER2-negative |
Phase II randomised open-label |
NCT03515798 |
| Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca |
Pembrolizumab |
HER2-negative |
Phase II, 2-cohort, open-label |
NCT02957968 |
| Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple-Negative Breast Cancer (NeoPACT) |
Pembrolizumab |
TNBC |
Phase II, open label |
NCT03639948 |
| Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer |
Atezolizumab |
TNBC |
Phase II, randomised, open label |
NCT02883062 |
| Nab-Paclitaxel and Atezolizumab Before Surgery in Treating Patients With Triple-Negative Breast Cancer |
Atezolizumab |
TNBC |
Phase II, open label |
NCT02530489 |
| Pembrolizumab in Treating Patients With Hormone Receptor-Positive, Localised Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy |
Pembrolizumab |
HR-positive, HER2-negative |
Phase II, open label |
NCT02971748 |
| Pembrolizumab in Treating Patients With Triple-Negative Breast Cancer |
Pembrolizumab |
TNBC |
Phase III, randomised, open label |
NCT02954874 |
| Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC (NIB) |
Pembrolizumab |
TNBC |
Phase II, one-arm, open-label |
NCT03289819 |
| Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Oestrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756) |
Pembrolizumab |
HR-positive, HER2-negative |
Phase III, randomised, double-blind |
NCT03725059 |
| Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer |
Nivolumab |
TNBC or HR-positive, HER2-negative |
Phase II, open label |
NCT03742986 |
| Study of Nivolumab Versus Placebo in Participants With High-Risk Breast Cancer (CheckMate 7FL) |
Nivolumab |
HR-positive, HER2-negative |
Phase III, randomised, double-blind, placebo-controlled |
NCT04109066 |
| Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo |
Atezolizumab |
TNBC |
Phase III, randomised, double-blind, |
NCT03281954 |
| Neoadjuvant Treatment of HER2-Positive Early High-Risk and Locally Advanced Breast Cancer (APTneo) |
Atezolizumab |
HER2-positive |
Phase III, randomised, open label |
NCT03595592 |
| A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early-Stage Triple-Negative Breast Cancer (IMpassion031) |
Atezolizumab |
TNBC |
Phase III, double-blind, randomised, placebo-controlled |
NCT03197935 |
| Trials with PD-1/PD-L1 inhibitors and CDK4/6 inhibitors |
| Neoadjuvant Study of Abemaciclib, Durvalumab and an Aromatase Inhibitor Early-Stage Breast Cancer |
Durvalumab |
HR-positive, HER2-negative |
Early Phase I |
NCT04088032 |
| A Study of Neoadjuvant Nivolumab + Abemaciclib or Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer (CheckMate 7A8) |
Nivolumab |
HR-positive, HER2-negative |
Phase II, randomised, non-comparative, multi-arm, |
NCT04075604 |
| Neoadjuvant Tamoxifen, Palbociclib, Avelumab in Oestrogen Receptor-Positive Breast Cancer (ImmunoADAPT) |
Avelumab |
HER2-positive |
Phase II, open label |
NCT03573648 |
| Trials with PD-1/PD-L1 inhibitors and anti-HER2 treatment |
| TAHP for Patients With HER2-positive Early Breast Cancer and Subsequent AHP Adjuvant Therapy After Surgery |
Atezolizumab |
HER2-positive |
Phase IB-II |
NCT03881878 |
| Atezolizumab in combination with trastuzumab emtansine or with trastuzumab and pertuzumab in patients with HER2-positive breast cancer and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer |
Atezolizumab |
HER2-positive |
Phase Ib, multi-cohort |
NCT02605915 |
| Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab |
Pembrolizumab |
HER2-positive |
Phase II open-label, randomised |
NCT03747120 |
| A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) |
Pembrolizumab |
HER2-positive |
Phase II, prospective, single arm, open label |
NCT03988036 |
| 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 (IMpassion050) |
Atezolizumab |
HER2-positive |
Phase III, randomised, double-Blind, placebo-controlled |
NCT03726879 |
| Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer (PREDIX II HER2) |
Atezolizumab |
HER2-positive |
Phase II, randomised, open label |
NCT03894007 |
| Trials with PD-1/PD-L1 inhibitors and Radiation treatment |
| Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab +/- Oleclumab in Luminal B Breast Cancer: (Neo-CheckRay) |
Durvalumab, Oleclumab |
Luminal B |
Phase II, randomised, open-label |
NCT03875573 |
| Breast Cancer Study of Pre-Operative Pembrolizumab + Radiation |
Pembrolizumab |
TNBC or HR-positive, HER2-negative |
Phase I/II, single arm with two cohorts |
NCT03366844 |
| Trials with vaccines |
| HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer |
Dendritic Cell Vaccine (DC1) |
HER2-positive |
Early Phase I |
NCT03387553 |
| HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy |
HER-2 pulsed Dendritic Cell Vaccine |
HER2-positive |
Phase I |
NCT02061423 |
| Safety and Immunogenicity of a Personalised Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy |
Personalised synthetic long peptide vaccine |
TNBC |
Phase I, single-arm |
NCT02427581 |
| Safety and Immunogenicity of a Personalised Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy |
Personalised polyepitope DNA vaccine |
TNBC |
Phase I open-label |
NCT02348320 |
| Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy |
Mammaglobin-A DNA Vaccine |
HR-positive, HER2-negative |
Phase IB |
NCT02204098 |
| Vaccination of High-Risk Breast Cancer Patients |
Chemovax |
HR-positive |
Phase I/II study, single-arm |
NCT02229084 |
| Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients |
NeuVax vaccine |
HER2-positive |
Phase II, prospective, randomised, single-blinded, placebo-controlled |
NCT02297698 |
| Vaccination of Triple-Negative Breast Cancer Patients |
P10s-PADRE with MONTANIDE™ ISA 51 VG |
TNBC |
Phase II, randomised two-arm, open-label |
NCT02938442 |
| Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple-Negative Breast Cancer |
Low dose FRα vaccine |
TNBC |
Phase II , randomised |
NCT02593227 |
| TPIV100 and Sargramostim for the Treatment of HER2-Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery |
Vaccine Therapy |
HER2-positive |
Phase II, randomised |
NCT04197687 |
|
Trials with PD-1/PD-L1 inhibitors in combination with other immunotherapy drugs |
| Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer (PROMETEO) |
Atezolizumab, T-VEC |
TNBC or HR-positive, HER2-negative |
Window opportunity, single arm, exploratory |
NCT03802604 |
| M7824 in Treating Patients With Stage II-III HER2-Positive Breast Cancer |
anti-PD-L1/TGFbetaRII fusion protein M7824 |
HER2-positive |
Phase I |
NCT03620201 |
| Converting HR+ Breast Cancer Into an Individualised Vaccine (CBCV) |
Pembrolizumab, CDX-301 |
HR-positive, HER2-negative |
phase II, randomised open-label |
NCT03804944 |
| Peri-Operative Ipilimumab+Nivolumab and Cryoablation Versus Standard Care in Women With Triple-Negative Breast Cancer |
Ipilimumab, nivolumab |
TNBC |
Phase II, randomised, open label |
NCT03546686 |
| TAC Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy and L-NMMA in Triple-Negative Breast Cancer |
Pembrolizumab |
TNBC |
Phase II, prospective, single arm, open label |
NCT04095689 |
| Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure (ULTIMATE) |
Durvalumab, Immune-attractant |
HR-positive, HER2-negative |
Phase II, open-label, single group assignment |
NCT02997995 |
| Durvalumab and Tremelimumab Before Surgery in Treating Patients With Hormone Receptor-Positive, HER2-Negative Stage II-III Breast Cancer |
Durvalumab and Tremelimumab |
HR-positive, HER2-negative |
Early phase I |
NCT03132467 |
| Pre-operative Immunotherapy Combination Strategies in Breast Cancer (ECLIPSE) |
Atezolizumab |
HR-positive, HER2-negative |
Phase II, open label, window of opportunity |
NCT03395899 |
| Other immunotherapeutic approaches |
| Immunogenicity and Safety of DCs in Breast Cancer (TEBICA) |
Dendritic cells |
All |
Phase I/II, randomised |
NCT03450044 |
| Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery |
HER2Bi-armed activated T cells |
TNBC |
Phase II, open label |
NCT01147016 |
| Intratumoural TriMix Injections in Early Breast Cancer Patients (TMBA) |
Trimix |
All |
Phase I |
NCT03788083 |
