Clinical trials: Breast Neoplasms, Triple-Negative
TNBC - Triple-Negative Breast Cancer
Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery
This is a Phase 3 trial to compare SRG-514 (active pharmaceutical ingredient [API]: ketorolac) administered intraoperatively to the tumor resection cavity with standard-of-care (SOC) versus SOC alone in participants with clinical…
- Trial name
- NCT07723469
- Testing
- BCS + SRG-514, BCS
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- SURGE Therapeutics
Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma
A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors
This study will evaluate the safety, tolerability, and preliminary antitumor activity of CAN04 both as a monotherapy and in combination with standard of care treatment in subjects with solid cancer tumors.
- Conditions
- Non Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Triple Negative Breast Cancer, Colorectal Cancer
- Trial name
- CANFOUR (NCT03267316)
- Testing
- CAN04, Cisplatin, Gemcitabine
- Where
- 25 sites in Austria, Belgium and 9 more
- Volunteers
- 167 people
- Sponsor
- Cantargia AB
TNBC, Triple Negative Breast Cancer
QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer
This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for…
- Trial name
- NCT07601178
- Testing
- TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ）
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Jiangsu Cancer Institute & Hospital
Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab…
- Trial name
- START-002 (NCT06827613)
- Testing
- STAR0602, Sacituzumab Govitecan (SG)
- Where
- 8 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Marengo Therapeutics, Inc.
Advanced Solid Tumors, Hematologic Neoplasms
A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with…
- Conditions
- Advanced Solid Tumors, Hematologic Neoplasms, Ovarian Cancer, HER2-positive Advanced Solid Tumors
- Trial name
- NCT03219268
- Testing
- tebotelimab 1 mg, tebotelimab 3 mg, tebotelimab 10 mg
- Where
- 40 sites in United States, Australia and 6 more
- Volunteers
- 277 people
- Sponsor
- MacroGenics
TNBC - Triple-Negative Breast Cancer
Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer
A real-world, multicenter, prospective study to evaluate the patient-reported outcome in Chinese patients who received sacituzumab govitecan or chemotherapy of the physician's choice for metastatic breast cancer progressing on…
- Trial name
- NCT07551050
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Fudan University
Neoadjuvant Therapy, Stage II to III (T1cN1-2 or T2-4N0-2) TNBC Breast Cancer
A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC)
This is a prospective, single center, phase II study to enroll participants with stage II or III TNBC who have not previously undergone systemic therapy. The primary endpoint is pCR in the ITT population.
- Trial name
- NCT07054242
- Testing
- Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Yantai Yuhuangding Hospital
Breast Cancer, TNBC - Triple-Negative Breast Cancer
First-line Nab-paclitaxel Plus Cisplatin Plus Camrelizumab in mTNBC Patients
To evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.
- Trial name
- NCT04537286
- Testing
- nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Fudan University
Breast Cancer
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with…
- Trial name
- NCT06112379
- Testing
- Dato-DXd, Durvalumab, Pembrolizumab
- Where
- 283 sites in United States, Australia and 24 more
- Volunteers
- 1,902 people
- Sponsor
- AstraZeneca
Breast Cancer
Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC
The hypothesis of this pilot trial is that administration of bortezomib will inhibit NHEJ in metastatic TNBC leading at the time of disease progression to metastases that are HR-deficient and sensitive to pembrolizumab and…
- Trial name
- NCT04265872
- Testing
- Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Baylor Research Institute
Triple Negative Breast Cancer, Neoadjuvant Immunotherapy
Observational Study on the Sensitivity of Neoadjuvant Immunotherapy in Early Triple-Negative Breast Cancer
Studies have reported that tumors with the same immunogenic mutations may induce T cell receptor (TCR) domains with similar antigen recognition functions.
- Conditions
- Triple Negative Breast Cancer, Neoadjuvant Immunotherapy, Sensitivity
- Trial name
- NCT06448169
- Testing
- PD-1 inhibitor
- Volunteers
- 200 people
- Sponsor
- Shandong University
Triple-Negative Breast Cancer (TNBC), Neoadjuvant Therapy
Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer（UPGRADE-TNBC）
This is a prospective, single-arm, multicenter study to observe and evaluate the efficacy and safety of paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab in neoadjuvant therapy for…
- Trial name
- UPGRADE-TNBC (NCT06910072)
- Testing
- paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Melanoma, Non-Small Cell Lung Cancer
A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors
This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in…
- Conditions
- Melanoma, Non-Small Cell Lung Cancer, Bladder Cancer, Colorectal Cancer
- Trial name
- NCT03289962
- Testing
- Autogene cevumeran, Atezolizumab
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 273 people
- Sponsor
- Genentech, Inc.
TNBC, Triple Negative Breast Cancer
A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC
Triple-negative breast cancer (TNBC) accounts for about 20% of breast cancers, is poorly differentiated, progresses rapidly, and frequently recurs, making it the subtype with the worst prognosis.
- Trial name
- NCT07178171
- Testing
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Pirarubicin, Nab-paclitaxel
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xijing Hospital
Cancer of the Breast, Breast Cancer
CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448)
The goal of this clinical study is to determine the safety, pharmacokinetics, pharmacodynamics and efficacy and activity of seviteronel, a lyase-selective inhibitor of CYP17, in patients with advanced breast cancer.
- Conditions
- Cancer of the Breast, Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- CLARITY-01 (NCT02580448)
- Testing
- Seviteronel
- Where
- 36 sites in United States
- Volunteers
- 175 people
- Sponsor
- Innocrin Pharmaceutical
Malignant Neoplasm of Breast, Breast Cancer
Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer
This study will test the theory that therapy designed for each individual's tumor will improve outcomes over standard of care in a population that needs a better standard.
- Trial name
- NCT02101385
- Testing
- Genomically Directed Monotherapy, Observation/Standard Therapy
- Where
- 29 sites in United States
- Volunteers
- 193 people
- Sponsor
- Bryan Schneider, MD
Triple Negative Breast Cancer
Cellular Immune Responses in Triple-negative Breast Cancer - High Throughput Immunogenetic Studies
This project introduces a novel methodology for the in-depth immunogenetic characterization of the TR gene repertoire in solid tumors, holding the promise to offer unprecedented insights into the TR anti-tumor specificity and the…
- Trial name
- NCT06646263
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- Institute of Applied Biosciences
Breast Cancer, Breast Cancer Stage II-III
Predictors of Response to Neoadjuvant Docetaxel-Carboplatin Chemotherapy for Patients With Stage II and III Triple Negative Breast Cancer
Neoadjuvant (preoperative) chemotherapy is an interesting research tool which allows investigators to test new drugs and/or new schedules with a validated surrogate endpoint, pCR.
- Trial name
- NCT01560663
- Testing
- Docetaxel- Carboplatin
- Where
- Spain
- Volunteers
- 415 people
- Sponsor
- Miguel Martín Jiménez
Metastatic Triple-Negative Breast Carcinoma
Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS
This is a prospective, multicenter, phase I/II, open-label, two-stage design of PD1+ TILs infusion in metastatic or advanced TNBC. TILS001 includes 3 parts.
- Trial name
- TILS001 (NCT05451784)
- Testing
- PD1+ TILs (NUMARZU-001) product infusion
- Where
- 4 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Fundacio Clinic Barcelona
PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with…
- Trial name
- NCT07111832
- Testing
- SHR-A1811 for Injection, SHR-1316 Injection, Toripalimab Injection
- Where
- 2 sites in China
- Volunteers
- 400 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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