Clinical trials: HER2-Positive Breast Carcinoma, open to volunteers
Locally Advanced or Metastatic Breast Cancers
Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.
This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer…
- Trial name
- TDXdose (NCT07195344)
- Testing
- Pharmacokinetics blood samples
- Where
- 10 sites in France
- Volunteers
- 210 people
- Sponsor
- Institut Claudius Regaud
Breast Cancer (Locally Advanced or Metastatic)
A Clinical Trial Comparing the Efficacy and Safety of Different Doses of BL0175 Injection in Treating Postmenopausal Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer
The goal of this clinical trial is to compare the objective response rates (ORR) of different doses of BL0175 in patients with postmenopausal hormone receptor (HR)-positive, human epidermal growth factor receptor 2…
- Trial name
- NCT07658183
- Testing
- BL0175 Injection
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai Best-Link Bioscience, LLC
HER2-positive Breast Cancer, LMD
Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study
The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy among patients with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer and LMD
- Trial name
- NCT06016387
- Testing
- Tucatinib 150 MG, Trastuzumab, Capecitabine
- Where
- 2 sites in Canada
- Volunteers
- 30 people
- Sponsor
- Sunnybrook Health Sciences Centre
Hormone Receptor Positive HER-2 Negative Breast Cancer
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care.
- Trial name
- NCT07459738
- Testing
- HLX43
- Volunteers
- 60 people
- Sponsor
- Shanghai Henlius Biotech
Breast Cancer
Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging
This study evaluates HER2-PET/CT-guided dynamic optimization of neoadjuvant therapy in patients with early-stage HER2-positive breast cancer.
- Trial name
- NCT07527806
- Testing
- Trastuzumab (Herceptin), Pertuzumab, Combination product: Trastuzumab + Pertuzumab
- Volunteers
- 156 people
- Sponsor
- Peking University Cancer Hospital & Institute
Breast Cancer
Treatment Intermittent Periods Based on ctDNA-MRD（Circulating Tumor DNA-minimal Residual Disease） Status in Advanced HER2-Positive Breast Cancer
Breast cancer seriously threatens the health of women worldwide. The HER-2-positive subtype accounts for approximately 15% to 20%, featuring strong invasiveness and poor prognosis.
- Trial name
- NCT07132502
- Testing
- ctDNA MRD
- Volunteers
- 24 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast Cancer, HER2-positive Breast Cancer
Entinostat Plus Pyrotinib and Endocrine Therapy in Advanced Triple-Positive Breast Cancer After Trastuzumab Failure
This is an open-label, single-center, exploratory, Phase Ib/II clinical trial evaluating the safety and efficacy of entinostat combined with pyrotinib and endocrine therapy in patients with advanced hormone receptor-positive…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-Positive Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT07708194
- Testing
- entinostat, Pyrotinib, endocrine therapy
- Where
- China
- Volunteers
- 94 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Breast Cancer, Breast Cancer Female
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain.
- Conditions
- Breast Cancer, Breast Cancer Female, Metastatic Triple-Negative Breast Carcinoma, ER Positive Breast Cancer
- Trial name
- NCT06176261
- Testing
- Datopotamab Deruxtecan
- Where
- 3 sites in United States
- Volunteers
- 58 people
- Sponsor
- Nancy Lin, MD
HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases
Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases
This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain…
- Trial name
- NCT07745257
- Testing
- Culmerciclib, Anlotinib, Endocrine Therapy
- Where
- 9 sites in China
- Volunteers
- 40 people
- Sponsor
- Sun Yat-sen University
Breast Cancer
Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors
This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor.
- Trial name
- NCT07258108
- Testing
- Lucanisatuzumab plus tagolimumab
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Sun Yat-sen University
Leucogen, Ribociclib
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer
This study is a multicenter, single-arm, open-label Phase II exploratory clinical trial designed to evaluate whether prophylactic use of leucogen can reduce the incidence of Grade 3 or higher neutropenia in early-stage HR+/HER2…
- Conditions
- Leucogen, Ribociclib, Neutropenia (Low White Blood Cell Count), Breast Cancer
- Trial name
- NCT07380646
- Testing
- Treat Regimen
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
HER2-positive Breast Cancer
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
The purpose of the study is to find out if an investigational drug called Dendritic Cell (DC1) vaccine added to standard neoadjuvant (given before main treatment) therapy can help people with HER2 (human epidermal growth factor…
- Trial name
- NCT05325632
- Testing
- HER-2 pulsed DC1, Trastuzumab, Pertuzumab
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
The goal of this clinical trial is to compare trastuzumab deruxtecan (T-DXd) to standard preoperative treatment in patients with non-metastatic HER2-positive breast cancer.
- Trial name
- ARIADNE (NCT05900206)
- Testing
- Trastuzumab deruxtecan, Docetaxel, Paclitaxel
- Where
- 7 sites in Sweden
- Volunteers
- 370 people
- Sponsor
- Karolinska University Hospital
Breast Cancer
To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer
- Trial name
- NCT06389006
- Testing
- Disitamab Vedotin for Injection, Toripalimab, Epirubicin
- Where
- China
- Volunteers
- 79 people
- Sponsor
- RemeGen Co., Ltd.
Breast Cancer
Exploratory Study of Neoadjuvant Treatment of HER2-positive Breast Cancer With Py in Combination With HP
This study is a single-arm, single-center exploratory clinical study. Twenty patients with early-stage HER2-positive breast cancer are planned to be included, and the primary objective is to evaluate the efficacy of neoadjuvant…
- Trial name
- NCT04929548
- Testing
- Pyrotinib Maleate Tablets
- Volunteers
- 20 people
- Sponsor
- Wuhan University
Breast Cancer, Hormone Receptor-positive Breast Cancer
VS-6766+Abema+Fulv in Met HR+/HER- BC
This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer.
- Conditions
- Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
- Trial name
- NCT05608252
- Testing
- VS-6766, Abemaciclib, Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- Adrienne G. Waks
Breast Cancer
Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.
- Trial name
- NCT02535221
- Testing
- Goserelin+TAM+AI, Epirubicin+CTX+5-Fu
- Where
- China
- Volunteers
- 234 people
- Sponsor
- Peking University
Breast Cancer
ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
- Trial name
- NCT06578286
- Testing
- ARX788
- Volunteers
- 44 people
- Sponsor
- Fudan University
ER-positive Breast Cancer, HER2-negative Breast Cancer
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse.
- Conditions
- ER-positive Breast Cancer, HER2-negative Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer
- Trial name
- TREAT ctDNA (NCT05512364)
- Testing
- Elacestrant, Tamoxifen, Letrozole 2.5mg
- Where
- 113 sites in Belgium, Cyprus and 10 more
- Volunteers
- 220 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
HER2-positive Early Breast Cancer
Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer
This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.
- Trial name
- TAYLOR (NCT07340398)
- Testing
- Nab paclitaxel, Carboplatin, Trastuzumab
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine