Clinical trials: Early Triple-Negative Breast Cancer
Triple-Negative Breast Neoplasm
Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC
A single-arm, single-institution study to induce phenotypic changes in the tumor microenvironment by delivering 8Gy partial breast irradiation in immune-cold triple-negative breast cancer confirmed by PD-L1 and TILs.
- Trial name
- KEY-MELT (NCT07011823)
- Testing
- Partial breast-irradiation
- Volunteers
- 20 people
- Sponsor
- Gangnam Severance Hospital
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Triple Negative Breast Cancer (TNBC)
The Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab Combined With Olaparib and Paclitaxel
Breast cancer is one of the most common malignant tumors in women, accounting for the first cancer-related death cause in women. In recent years, the incidence has gradually increased, and the trend is younger.
- Trial name
- NCT07187674
- Testing
- Iparomlimab and tuvonralimab combined with olaparib and paclitaxel
- Volunteers
- 20 people
- Sponsor
- Harbin Medical University
Breast Cancer
Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer
To explore the application of Camrelizumab with chemotherapy as neoadjuvant treatment of early-stage TNBC. Phase II clinical study of Camrelizumab in neoadjuvant treatment of early-stage TNBC is proposed.
- Trial name
- Camella (NCT07107217)
- Testing
- Camrelizumab, Doxorubicin +cyclophosphamide+ filgrastimum, carboplatin + paclitaxel (CP)
- Volunteers
- 40 people
- Sponsor
- Blokhin's Russian Cancer Research Center
Breast Cancer
Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients
This is a prospective, open-label, randomized phase III study assessing adjuvant capecitabine after standard chemotherapy for patients with early triple negative breast cancer.
- Trial name
- NCT00130533
- Testing
- Capecitabine
- Where
- 48 sites in Spain
- Volunteers
- 876 people
- Sponsor
- Spanish Breast Cancer Research Group
Triple-negative Breast Cancer
Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC
Triple-negative breast cancer (TNBC) is a group of tumors that occurs mainly in young, premenopausal women and accounts for 10-20% of breast cancers.
- Trial name
- ETNA (NCT06078384)
- Testing
- Pembrolizumab 25 mg/ml, Paclitaxel injection
- Where
- 44 sites in France, Spain
- Volunteers
- 354 people
- Sponsor
- UNICANCER
Early Small (cT1N0) Triple Negative Breast Cancer
Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva)
This study aims to evaluate the efficacy and safety of preoperative Durvalumab in patients with early small (cT1N0) triple negative breast cancer tumors.
- Trial name
- POP-DURVA (NCT05215106)
- Testing
- Durvalumab
- Where
- 3 sites in France
- Volunteers
- 200 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Early Stage Triple-Negative Breast Carcinoma, Metastatic Bladder Urothelial Carcinoma
Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform
This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.
- Conditions
- Early Stage Triple-Negative Breast Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Cervical Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma
- Trial name
- ELEPHAS-04 (NCT06349642)
- Testing
- Biospecimen Collection, Tissue Collection
- Where
- 3 sites in United States
- Volunteers
- 324 people
- Sponsor
- Mayo Clinic
Breast Cancer
Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer
The purpose of this study is to determine the impact of pre-operative cryoablation, and immune checkpoint inhibition (ICI) on on 3-year Event Free Survival (EFS), in women with residual hormone receptor negative, HER2-negative…
- Trial name
- NCT03546686
- Testing
- Pembrolizumab, Core Biopsy/Cryoablation, Breast Surgery
- Where
- 4 sites in United States
- Volunteers
- 51 people
- Sponsor
- University of Texas Southwestern Medical Center
Breast Cancer Metastatic
Zoledronic Acid Combined With EC-T for Triple-Negative Breast Cancer
Exploring the efficacy and safety of zoledronic acid combined with neoadjuvant chemotherapy (EC-T) in neoadjuvant treatment for early-stage or locally advanced triple-negative breast cancer, the trial protocol of zoledronic acid…
- Trial name
- NCT06876636
- Testing
- Zoledronic Acid Combined with Neoadjuvant Chemotherapy (EC-T)
- Where
- China
- Volunteers
- 99 people
- Sponsor
- Xijing Hospital
Triple-negative Breast Cancer
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
This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and…
- Trial name
- IMpassion031 (NCT03197935)
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Nab-paclitaxel, Doxorubicin
- Where
- 68 sites in United States, Australia and 11 more
- Volunteers
- 333 people
- Sponsor
- Hoffmann-La Roche
TNBC, Triple Negative Breast Cancer
TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer
Refining neoadjuvant chemoimmunotherapy and establishing predictive biomarkers remain pivotal challenges in early TNBC. Although SG/I (sacituzumab govitecan/PD-1 inhibitor) shows clinical promise, validation of responder…
- Trial name
- TREND-02 (NCT07271992)
- Testing
- SG+I
- Volunteers
- 30 people
- Sponsor
- First Hospital of China Medical University
Breast Neoplasm, Breast Neoplasm, Male
Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate to neoadjuvant anthracycline-based and…
- Conditions
- Breast Neoplasm, Breast Neoplasm, Male, Triple Negative Breast Cancer
- Trial name
- NCT02950259
- Testing
- Cyclophosphamide, Indomethacin, Omeprazole
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Providence Health & Services
Breast Cancer
TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC
This is a phase II clinical study testing a more personalized and lighter chemotherapy approach for women with stage I or II triple-negative breast cancer.
- Trial name
- DespaTIL (NCT07074106)
- Testing
- Carboplatin and a Taxane
- Where
- 5 sites in Brazil
- Volunteers
- 40 people
- Sponsor
- D'Or Institute for Research and Education
Triple Negative Breast Cancer
PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
Eligible patients with stage 2 and 3 triple negative breast cancer will be treated with 4 cycles of neoadjuvant paclitaxel/carboplatin/pembrolizumab. A PET scan will be performed at baseline and after 1 cycle of therapy.
- Trial name
- NeoADAPT (NCT06245889)
- Testing
- Paclitaxel, Carboplatin, Pembrolizumab
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breast Cancer, Triple Negative Breast Neoplasms
A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer
The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug taxane, will improve the results of the treatment for early- stage Triple Negative Breast…
- Conditions
- Breast Cancer, Triple Negative Breast Neoplasms, Triple-Negative Breast Neoplasm, Triple-Negative Breast Cancer
- Trial name
- NCT02685306
- Testing
- Bavituximab, Taxane
- Sponsor
- Peregrine Pharmaceuticals
Triple Negative Breast Cancer
A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
The purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants…
- Trial name
- NCT04613674
- Testing
- Camrelizumab Plus Chemotherapy
- Where
- China
- Volunteers
- 441 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer Female, Triple Negative Breast Cancer
The Study of Quadruple Therapy Quercetin, Zinc, Metformin, and EGCG as Adjuvant Therapy for Early, Metastatic Breast Cancer and Triple-negative Breast Cancer, a Novel Mechanism
breast cancer is the most common cancer in women. With more than 1 in 10 new cancer diagnoses each year, It is the second most frequent cancer-related death among women worldwide.
- Trial name
- NCT05680662
- Testing
- quercetin, EGCG, metformin , zinc
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Saudi Arabia
Breast Neoplasm, Breast Cancer
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for…
- Conditions
- Breast Neoplasm, Breast Cancer, Breast Tumors, Triple-Negative Breast Cancer (TNBC)
- Trial name
- FASCINATE-N (NCT05582499)
- Testing
- Dalpiciclib, Pyrotinib, SHR-A1811
- Where
- China
- Volunteers
- 716 people
- Sponsor
- Fudan University
Triple Negative Breast Cancer, PD-L1 Negative
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally…
- Trial name
- ASCENT-03 (NCT05382299)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, nab-Paclitaxel
- Where
- 363 sites in United States, Argentina and 28 more
- Volunteers
- 623 people
- Sponsor
- Gilead Sciences