Clinical trials: Locally Advanced Triple-Negative Breast Carcinoma
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.
Triple Negative Breast Cancer, HER2-negative Breast Cancer
A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
A phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas
- Conditions
- Triple Negative Breast Cancer, HER2-negative Breast Cancer, Non Small Cell Lung Cancer, Cervical Cancer
- Trial name
- NCT06999187
- Testing
- DR-0202
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Dren Bio
HER2-negative Breast Cancer, Metastatic Breast Cancer
Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
This is a research study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced…
- Conditions
- HER2-negative Breast Cancer, Metastatic Breast Cancer, Metaplastic Breast Carcinoma, TNBC - Triple-Negative Breast Cancer
- Trial name
- NCT05660083
- Testing
- L-NMMA
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- The Methodist Hospital Research Institute
Triple Negative Breast Cancer (TNBC), High Grade Serous Ovarian Carcinoma
Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications
BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx).
- Conditions
- Triple Negative Breast Cancer (TNBC), High Grade Serous Ovarian Carcinoma, High Grade Endometrial Carcinoma, Anogenital Cancer
- Trial name
- POTENTIATE (NCT05827614)
- Testing
- BBI-355, Erlotinib, Futibatinib
- Where
- 16 sites in United States
- Volunteers
- 85 people
- Sponsor
- Boundless Bio, Inc.
Triple Negative Breast Cancer, Immune Checkpoint Inhibitor
Granzyme B-PET: Predicting Immunotherapy Efficacy in TNBC
This study plans to enroll 30 patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who are scheduled to receive at least two cycles of a regimen containing an immune checkpoint inhibitor (ICI).
- Conditions
- Triple Negative Breast Cancer, Immune Checkpoint Inhibitor, Granzyme B PET/CT
- Trial name
- NCT07705438
- Testing
- [68Ga]Ga-DOTA-GSI PET/CT (Granzyme B PET/CT)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Fudan University
Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer
This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).
- Trial name
- NCT04699630
- Testing
- U3-1402
- Where
- 11 sites in United States
- Volunteers
- 121 people
- Sponsor
- SCRI Development Innovations, LLC
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Cryoablation, Atezolizumab/Nab-paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
This early phase I trial studies the side effects and feasibility of cryoablation, atezolizumab, and nab-paclitaxel in treating patients with triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally…
- 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
- NCT04249167
- Testing
- Atezolizumab, Cryosurgery, Nab-paclitaxel
- Sponsor
- Mayo Clinic
Breast Cancer
FMD and Neoadjuvant Chemo-immunotherapy in TNBC
The primary objective of this study is to investigate the efficacy and safety of a fasting-mimicking diet (FMD) intervention combined with standard neoadjuvant chemoimmunotherapy in early-stage or locally advanced triple-negative…
- Trial name
- FACT-TN (NCT07378306)
- Testing
- Fasting-mimicking diet, Chemotherapy, Toripalimab
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sun Yat-sen University
Advanced Triple-Negative Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8
Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer
This phase II trial studies how well estradiol works in treating patients with estrogen receptor beta (ER beta) positive, triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other…
- Conditions
- Advanced Triple-Negative Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma
- Trial name
- NCT03941730
- Testing
- Biopsy, Computed Tomography, Magnetic Resonance Imaging
- Where
- 9 sites in United States
- Volunteers
- 8 people
- Sponsor
- Mayo Clinic
Breast Cancer, Ovarian Epithelial Cancer Recurrent
Mifepristone and Eribulin in Patients With Metastatic Triple Negative Breast Cancer or Other Specified Solid Tumors
This is a study to assess the safety of the combination of mifepristone and eribulin in patients with metastatic or locally advanced unresectable breast or other specified solid tumors, and determine preliminary efficacy of the…
- Conditions
- Breast Cancer, Ovarian Epithelial Cancer Recurrent, Sarcoma, Non-small Cell Lung Cancer
- Trial name
- NCT02014337
- Testing
- Mifepristone and Eribulin in combination
- Where
- 11 sites in United States
- Volunteers
- 37 people
- Sponsor
- Corcept Therapeutics
Triple-Negative Breast Cancer (TNBC)
Combination Immunotherapy Treatment for Locally Advanced Unresectable or Metastatic, PD-L1 Negative (CPS<10), gBRCA Negative, Triple Negative Breast Cancer Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy
The objective of this study is to evaluate the safety, feasibility, and preliminary antitumor activity of this multi-component immunotherapy strategy in patients with advanced solid tumors.
- Trial name
- NCT07762703
- Testing
- BreakVax, Ipilimumab 2.5 mg, Pembrolizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- BreakBio Corp
Triple Negative Breast Cancer
Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC
Trilaciclib is a highly potent, selective, and reversible CDK4/6 inhibitor that protects bone marrow by protecting hematopoietic stem cells and progenitor cells (HSPCs) during systemic chemotherapy.
- Trial name
- NCT06955156
- Testing
- Trilaciclib
- Where
- China
- Volunteers
- 50 people
- Sponsor
- QIAO LI
Breast Cancer
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer or Other Solid Tumors
In phase Ia study, the safety and tolerability of BL-M02D1 in patients with locally advanced or metastatic triple negative breast cancer or other solid tumors will be investigated to determine the dose-limiting toxicity (DLT)…
- Trial name
- NCT05339685
- Testing
- BL-M02D1
- Where
- 10 sites in China
- Volunteers
- 82 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Advance Solid Tumors
A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of KIVU-107, a PTK7-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.
- Trial name
- NCT07229313
- Testing
- KIVU-107
- Where
- 7 sites in United States, Australia
- Volunteers
- 76 people
- Sponsor
- Kivu Bioscience Inc.
Triple-Negative Breast Cancer
Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer
The study is being conducted to evaluate VEGFR BP102 with nab-paclitaxe or treatment of physician's choice (TPC) versus nab-paclitaxe or TPC in patients for basal-like immune suppressed (BLIS) subtype of triple-negative breast…
- Trial name
- BCTOP-T-M01 (NCT05806060)
- Testing
- VEGFR and TPC, TPC
- Where
- China
- Volunteers
- 134 people
- Sponsor
- Fudan University
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, Triple Negative Breast Cancer
Olaparib in Locally Advanced ER, PgR and HER2 Negative (Triple Negative) and in Locally Advanced Germline BRCA Mutation-positive Breast Cancer Patients
Treatment selection for breast cancer is still largely empiric and guided by large randomized clinical trials on populations of patients. This approach is inadequate for the selection of individualized chemotherapy regimens.
- Trial name
- NCT02681562
- Testing
- olaparib
- Volunteers
- 45 people
- Sponsor
- Istituti Ospitalieri di Cremona
Triple Negative Breast Cancer (TNBC)
Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
This Phase II/III study assessed the efficacy, safety, pharmacokinetics, and immunogenicity of B013 administered with nab-paclitaxel in participants with locally advanced or metastatic triple negative breast cancer (TNBC) who…
- Trial name
- NCT05555706
- Testing
- B013+Nab-Paclitaxel
- Where
- 13 sites in China
- Volunteers
- 62 people
- Sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
Locally Advanced Malignant Neoplasm, Inflammatory Breast Carcinoma
Olaparib and Radiotherapy in Inoperable Breast Cancer
The majority of breast cancer patients receive radiotherapy as part of their treatment. Radiotherapy improves both locoregional control and overall survival.
- Conditions
- Locally Advanced Malignant Neoplasm, Inflammatory Breast Carcinoma, Triple-Negative Invasive Breast Carcinoma
- Trial name
- NCT02227082
- Testing
- radiotherapy, olaparib
- Where
- Netherlands
- Volunteers
- 7 people
- Sponsor
- The Netherlands Cancer Institute