Clinical trials: Unresectable Triple-Negative Breast Carcinoma
Metastatic Triple-Negative Breast Cancer
Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer
The goal of this phase II study is to test the combination of trilaciclib, pembrolizumab, gemcitabine, and carboplatin in locally advanced unresectable or metastatic triple-negative breast cancer.
- Trial name
- ToPCourT (NCT06027268)
- Testing
- Trilaciclib, Pembrolizumab, Gemcitabine
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Wake Forest University Health Sciences
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors
This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
- Trial name
- PNeoVCA (NCT05269381)
- Testing
- Cyclophosphamide, Neoantigen Peptide Vaccine, Pembrolizumab
- Where
- United States
- Volunteers
- 138 people
- Sponsor
- Mayo Clinic
Triple-Negative Breast Cancer
A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.
- Trial name
- NCT04177108
- Testing
- Atezolizumab, Ipatasertib, Paclitaxel
- Where
- 182 sites in United States, Argentina and 35 more
- Volunteers
- 242 people
- Sponsor
- Hoffmann-La Roche
Triple-negative Breast Cancer and HR+/HER2- BC
SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
The purpose of this study is to assess the safety and tolerability and preliminary antitumor activity of SKB264 with/without KL-A167 in patients with unresectable locally advanced, recurrent or metastatic TNBC and HR+/HER2- BC…
- Trial name
- NCT05445908
- Testing
- SKB264, KL-A167
- Where
- 2 sites in China
- Volunteers
- 184 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Breast Adenocarcinoma, Metastatic Triple-Negative Breast Carcinoma
Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer
This phase I/II trial studies the best dose of pembrolizumab and binimetinib and how well it works when given together with pembrolizumab in treating patients with triple negative breast cancer that has spread to other parts of…
- Conditions
- Breast Adenocarcinoma, Metastatic Triple-Negative Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7
- Trial name
- NCT03106415
- Testing
- Binimetinib, Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Mayo Clinic
TNBC
A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC
Here, the investigators present the results from a Phase Ib/II study of PM8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.
- Trial name
- NCT05918133
- Testing
- PM8002, nab-paclitaxel
- Where
- 8 sites in China
- Volunteers
- 42 people
- Sponsor
- Biotheus Inc.
Unresectable Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer
TROPION Breast Respond in 1L TNBC
There are no real-world data available on the effectiveness and safety of Dato-DXd in adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
- Trial name
- NCT07867470
- Testing
- Dato-DXd
- Volunteers
- 400 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Triple Negative Breast Neoplasms
A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC
This is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of sacituzumab govitecan plus toripalimab versus toripalimab plus nab-paclitaxel in patients with previously untreated, unresectable…
- Trial name
- NCT07040644
- Testing
- Sacituzumab Govitecan (SG), Toripalimab, Nab-paclitaxel
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Triple-Negative Breast Cancer
A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer
Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received…
- Trial name
- EL1SSAR (NCT04148911)
- Testing
- Atezolizumab, Nab-Paclitaxel
- Where
- 67 sites in Argentina, Chile and 11 more
- Volunteers
- 184 people
- Sponsor
- Hoffmann-La Roche
Triple-negative Breast Cancer
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.
- Trial name
- NCT06471205
- Testing
- BL-B01D1, PD-1 Monoclonal Antibody
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Cancer Female, Triple Negative and Androgen Receptor Positive
Study on Androgen Receptor and Triple Negative Breast Cancer
This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two…
- Trial name
- START (NCT03383679)
- Testing
- Darolutamide, Capecitabine
- Where
- France
- Volunteers
- 94 people
- Sponsor
- UNICANCER
TNBC - Triple-Negative Breast Cancer, PD-L1 Positive
Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a/mTNBC
This study is aimed to evaluate the efficacy and safety of Sacituzumab Tirumotecan combined with Toripalimab for first-line treatment of PD-L1 positive unresectable Locally Advanced/metastatic triple negative breast cancer…
- Trial name
- NCT07244874
- Testing
- Sacituzumab tirumotecan, Toripalimab
- Volunteers
- 41 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Triple-Negative Breast Cancer
A Trial of Camrelizumab in Combination With Nab-paclitaxel and Famitinib as a First Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer(FUTURE-C-PLUS)
The study is being conducted to evaluate the efficacy, safety of camrelizumab in combination with nab-paclitaxel and famitinib in Patients with unresectable locally advanced or metastatic immunomodulatory triple negative breast…
- Trial name
- NCT04129996
- Testing
- camrelizumab in combination with nab-paclitaxel and famitinib
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Fudan University
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies
This phase I trial studies the side effects and best dose of genetically modified T-cell therapy in treating patients with receptor tyrosine kinase-like orphan receptor 1 positive (ROR1+) chronic lymphocytic leukemia (CLL)…
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Triple-Negative Breast Carcinoma
- Trial name
- NCT02706392
- Testing
- Laboratory Biomarker Analysis, ROR1 CAR-specific Autologous T-Lymphocytes
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Fred Hutchinson Cancer Center
Breast Neoplasms, Triple Negative Breast Cancer
Real-world Study of Sacituzumab Govitecan Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer
This multicenter observational real-world study is planned to enroll 100 patients, divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor…
- Conditions
- Breast Neoplasms, Triple Negative Breast Cancer, HR+, HER2-, Advanced Breast Cancer, Breast Cancer
- Trial name
- NCT07018427
- Testing
- Sacituzumab Govitecan Monotherapy or Combination Therapy
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Peking University Cancer Hospital & Institute
Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix
7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007)
This phase I trial is studying the side effects and best dose of giving 7-hydroxystaurosporine together with irinotecan hydrochloride in treating patients with metastatic or unresectable solid tumors, including triple-negative…
- Conditions
- Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Estrogen Receptor-negative Breast Cancer, Extensive Stage Small Cell Lung Cancer
- Trial name
- NCT00031681
- Testing
- 7-hydroxystaurosporine, irinotecan hydrochloride, diagnostic laboratory biomarker analysis
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- National Cancer Institute (NCI)
Triple Negative Breast Cancer
A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care
Primary Endpoint of this Study: To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee [BIRC] based on Response Evaluation Criteria in Solid Tumors [RECIST v1.1]) between JSKN016 and…
- Trial name
- NCT07533123
- Testing
- JSKN016 Injection, Eribulin Mcsilate Injection, Vinorelbine Tartrate Injection
- Where
- China
- Volunteers
- 364 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
This phase I trial tests the safety, side effects, and best dose of ASTX727 when given in combination with a usual approach of treatment with paclitaxel and pembrolizumab in patients with triple-negative breast cancer that has…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Unresectable Triple-Negative Breast Carcinoma
- Trial name
- NCT05673200
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 10 sites in United States
- Volunteers
- 32 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer, Invasive Breast Cancer
Onvansertib + Paclitaxel In TNBC
This research is being done to evaluate the safety and effectiveness of Onvansertib in combination with Paclitaxel in triple-negative breast cancer (TNBC) that has spread to other parts of the body.
- Conditions
- Breast Cancer, Invasive Breast Cancer, Unresectable Breast Carcinoma, Locally Advanced Breast Cancer
- Trial name
- NCT05383196
- Testing
- Onvansertib, Paclitaxel
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Antonio Giordano, MD
Advanced Solid Tumors, Non-Small Cell Lung Cancer
A Study of IOV-5001 in Adults With Advanced Solid Tumors
A Phase 1/2, multicenter, multi-cohort, open-label study of an autologous tumor-infiltrating lymphocytes (TIL) regimen with IOV-5001 in participants with previously treated advanced solid tumors
- Conditions
- Advanced Solid Tumors, Non-Small Cell Lung Cancer, Triple Negative Breast Cancer (TNBC), Colorectal Cancer
- Trial name
- NCT07743723
- Testing
- IOV-5001
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Iovance Biotherapeutics, Inc.