Table 2 Ongoing phase II/III clinical trials investigating TILs as a biomarker in invasive breast cancer.
Trial identifier and phase | Sample size | Setting | Purpose | Estimated primary completion date | Sponsor |
|---|---|---|---|---|---|
NCT04188119 (IMpALA) Phase II | 42 | Triple-negative breast cancer (TNBC) | Assessment of post treatment tumor-infiltrating lymphocytes (TILs) by immunohistochemistry (as secondary outcome measure) | June 2021 | The Christie NHS Foundation Trust |
NCT03863301 (ABLATIVE-2) Phase II | 70 | Non-lobular invasive BC | Assessment TILs at baseline on biopsies and after surgery and their correlation with the pathological response (as a secondary outcome measure) | November 2022 | UMC Utrecht, Netherland |
NCT03820141 (DTP Trial) Phase II | 39 | HER2-amplified BC | Correlation of pathological complete response rate in BC patients with TILs (as secondary outcome measure) | March 2023 | AstraZeneca |
NCT03359954 Phase II | 20 | HR+/ HER2- BC | Evaluation of changes in TILs as a continuous variable before and after preoperative radiotherapy (RT) (as primary objective) | October 2019 | M.D. Anderson Cancer Center |
NCT03971045 (PERICLES) Phase II | 46 | Locally advanced “chest wall” BC | Positive PD-L1 (≥1%) and/or TILs (≥1%) as biomarkers for patient selection in locally advanced BC previously treated with chemotherapy or radiation therapy | July 2021 | European Institute of Oncology |
NCT02883062 Phase II | 72 | Newly diagnosed, stage II-III TNBC | Comparison of TILs percentage, PD-L1 and neoantigen load at baseline before and after therapy in patients receiving neoadjuvant chemotherapy (NACT) alone and those treated with NACT and atezolizumab in a randomized fashion | July 2020 | National Cancer Institute (NCI) |
NCT03366844 PhaseI/II | 60 | Invasive BC | TILs score changes (by Salgado et al. criteria) | January 2021 | Cedars-Sinai Medical Center |
NCT02435680 Phase II | 50 | Advanced TNBC with high tumor-associated macrophages (TAMs) | Assessment of TILs and TAMs content in pre- and post-dose tumor biopsies (as secondary outcome measure) | December 2019 | Novartis Pharmaceuticals |
NCT03894007 (PREDIX II HER2) Phase II | 190 | HER2-amplified early BC | TILs and gut microbiota as predictors of treatment response in patients receiving atezolizumab in a randomized fashion | December 2024 | Karolinska University Hospital, Sweden |
NCT03004183 (STOMP) Phase II | 57 | Metastatic TNBC | Measurement of the changes of TILs in tumor biopsy tissues as a biomarker of response to ADV/HSV-tk + valacyclovir therapy in combination with stereotactic body radiation therapy followed by immune-checkpoint blockade | May 2022 | Merck Sharp & Dohme Corp. |
NCT03979508 (BEAUTY Study) Phase II | 100 | Surgically resectable and chemotherapy-resistant TNBC | Quantification of TILs in TNBC patients treated with abemaciclib | July 2022 | Mayo Clinic in collaboration with NCI |
NCT02003209 Phase III | 312 | Locally advanced BC | Quantification of TILs in BC patients treated with neoadjuvant chemotherapy, trastuzumab, and pertuzumab with or without estrogen deprivation | August 2021 | NCI |
NCT02990845 (PEER) Phase I/II | 25 | Premenopausal HR+/ HER2- locally advanced or metastatic BC | Study of potentially predictive biomarkers of the efficacy of the combination of pembrolizumab and exemestane/leuprolide including TILs, PD-L1, circulating tumor cells, and mutational load | December 2019 | National Taiwan University Hospital in collaboration with Merck Sharp & Dohme Corp. |
NCT03125928 Phase II | 50 | Metastatic HER2-positive BC | Investigation of predictive biomarkers of response (PD-L1 and TILs) to immune-checkpoint blockade (as secondary outcome measure) | December 2020 | Fox Chase Cancer Center in collaboration with Genentech, Inc. |
NCT02971761 Phase II | 29 | Androgen receptor-positive metastatic TNBC | Evaluation of pre-treatment PD-L1 and TILs as predictive biomarkers of pembrolizumab and enobosarm | November 2020 | City of Hope Medical Center in collaboration with NCI |
NCT02849496 | 72 | Locally advanced or metastatic non-HER2-positive BC | Measurement of TILs level changes in patients treated with olaparib with or without atezolizumab | August 2020 | NCI |
NCT02536794 Phase II | 30 | Metastatic HER2-negative BC | Evaluation of tissue-based immunohistochemical expression TILs, PD-L1, and other immune-related candidate biomarkers as predictors of response to MEDI4736 in combination with tremelimumab (as secondary outcome measure) | September 2019 | Northwestern University in collaboration with MedImmune LLC Avon Breast Cancer Foundation and NCI |
NCT03289819 Phase II | 50 | Early TNBC | Assessment of stromal and intratumoral TILs collected at baseline, 12 weeks after treatment initiation, and at the surgery | November 2019 | Institute for Women’s Health in collaboration with Merck Sharp & Dohme Corp. And Celgene Corporation |
NCT03740893 (PHOENIX) Phase II | 81 | NACT resistant and residual TNBC | Study of frequency and function of subsets of TILs in patients treated with DNA damage response inhibition and/or immune-checkpoint blockade (as secondary outcome measure) | May 2021 | Institute of Cancer Research, the United Kingdom in collaboration with AstraZeneca |
