Clinical trials: HER2 Expression
Breast Cancer Metastatic
HER2-PET: Predicting T-DXd Efficacy and HER2 Heterogeneity
The study will be conducted as an open-label, single-center, Phase II clinical study, with a planned enrollment of 86 patients with locally advanced or metastatic HER2-positive and HER2-low breast cancer who are intended to…
- Trial name
- PREDICT-HER (NCT07586215)
- Testing
- PET
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fudan University
HER2-positive Breast Cancer
A Study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer
A large multi- center phase II/III study with 68Ga-ABY-025 PET and biopsies in patients with advanced HER2-positive breast cancer, where the primary endpoint of the study is to find out the correlation between the HER2 expression…
- Trial name
- Affibody-3 (NCT03655353)
- Testing
- ABY-PET
- Where
- Sweden
- Volunteers
- 160 people
- Sponsor
- Henrik Lindman
Ovarian Cancer
SHR - A1811 Versus Chemotherapy for Platinum-resistant Recurrent Epithelial Ovarian Cancer
This study is a randomized, open-label, active-controlled, multicenter phase III clinical trial. It is planned to enroll 300 subjects with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary…
- Trial name
- NCT06990503
- Testing
- SHR-A1811, Chemotherapy
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Tongji Hospital
HER2-positive Breast Cancer
A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection…
- Trial name
- NCT07043725
- Testing
- TQB2102 for injection, Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection
- Where
- 78 sites in China
- Volunteers
- 544 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
HER2 Overexpression, Advanced Stage Breast Cancer
A Real-world Clinical Study of T-DXd for the Treatment of Chinese Patients With HER2 Overexpressing and HER2 Underexpressing Advanced Breast Cancer
The study is an open, prospective study to collect data on the efficacy and safety of T-DXd (DS8201) in Chinese patients with HER2 overexpressing and HER2 underexpressing advanced breast cancer in actual clinical practice in…
- Conditions
- HER2 Overexpression, Advanced Stage Breast Cancer, Low Expression of HER2
- Trial name
- NCT07035353
- Testing
- T-DXd (DS8201) 5.4 mg/kg, IVD, 1 cycle every 21 days.
- Volunteers
- 200 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
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
Research on AI Models for Predicting Breast Cancer Treatment Effectiveness to Guide Her-2 Targeted ADC Therapy
This study aims to develop an AI-based predictive tool to help clinicians more accurately determine whether breast cancer patients can benefit from HER-2-targeted antibody-drug conjugate (T-DXd) therapy before treatment.
- Trial name
- NCT07689929
- Where
- China
- Volunteers
- 900 people
- Sponsor
- Zhejiang Cancer Hospital
NMIBC
A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.
This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment…
- Trial name
- NCT06630871
- Testing
- Distitamab Vedotin in combination with Tislelizumab
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Fujian Medical University Union Hospital
Breast Cancer
Phase II Trial of Neoadjuvant[FEC100]/Cisplatin-Docetaxel ± Trastuzumab in Women With Over Expressed or Amplified Her2/Neu With Locally Advanced Breast Cancer
Phase II trial of Neoadjuvant [FEC100]/Cisplatin-Docetaxel ± Trastuzumab in women with over expressed or amplified Her2/Neu with Locally advanced Breast Cancer
- Trial name
- NCT00535509
- Testing
- Cisplatin-Docetaxel ± Trastuzumab
- Volunteers
- 285 people
- Sponsor
- King Faisal Specialist Hospital & Research Center
Breast Cancer
Studying Tissue Samples From Women With Breast Cancer Who Were Treated on Clinical Trial NCCTG-N9831
This research study is looking at tissue samples from women with breast cancer who were treated on clinical trial NCCTG-N9831. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more…
- Trial name
- NCT00898898
- Testing
- diagnostic laboratory biomarker analysis
- Volunteers
- 2,837 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Ovarian Carcinoma, Fallopian Tube Carcinoma
RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression
The purpose of this study is to evaluate the efficacy, safety, and quality of life scores of patients with HER2-expressing platinum-sensitive recurrent epithelial ovarian cancer treated with the combination therapy regimen of…
- Conditions
- Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
- Trial name
- NCT06420973
- Testing
- RC48+carboplatin±bevacizumab
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Peking University Cancer Hospital & Institute
Gastric Cancer, HER-2
Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks
One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu) immunohistochemistry (IHC) assessment.
- Trial name
- NCT02852096
- Testing
- Dual or Multiple Paraffin Blocks, One Paraffin Blocks
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Shanghai Zhongshan Hospital
Biliary Tract Neoplasms Immunotherapy
Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer
This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low…
- Trial name
- NCT07670273
- Testing
- Trastuzumab Rezetecan, Adebrelimab, Lenvatinib
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Peking Union Medical College Hospital
Esophageal Cancer, Gastric Cancer
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors
This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in…
- Conditions
- Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Colorectal Cancer
- Trial name
- NCT06500052
- Testing
- BL-M17D1
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Metastatic Breast Cancer
T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer
This open-label, single-center Phase Ib study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) with Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer.
- Trial name
- STELA (NCT02073916)
- Testing
- T-DM1, Lapatinib, Abraxane
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Jenny C. Chang, MD
Metastatic Breast Carcinoma, Locally Advanced Breast Cancer
Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients
Study objective: Cohort 1: To quantify the uptake of 68GaNOTA-Anti-HER2 VHH1 in local or distant metastases from breast carcinoma patients and to assess repeatability of the image-based HER2 quantification.
- Conditions
- Metastatic Breast Carcinoma, Locally Advanced Breast Cancer, Cancer of Pancreas, Solid Tumor With Intermediate or High HER2 Expression
- Trial name
- VUBAR (NCT03924466)
- Testing
- 68GaNOTA-Anti-HER2 VHH1
- Where
- Belgium
- Volunteers
- 55 people
- Sponsor
- Universitair Ziekenhuis Brussel
HER2-zero, HER2-low and HER2-positive Tumors Distribution Across HR Expression Categories
Clinico-pathological and Genomic Features of HER2-low Early Breast Cancer
Although breast cancer remains one of the most common and fatal cancer types among women worldwide, earlier diagnosis and improved therapeutic approaches have led to decreased mortality over last years.
- Trial name
- NCT07561346
- Where
- Greece
- Volunteers
- 3,648 people
- Sponsor
- Hellenic Cooperative Oncology Group
Metastatic Breast Cancer
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns
The purpose of this observational study is to learn about the HER2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer.
- Trial name
- HEROIC (NCT06551220)
- Testing
- Trastuzumab Deruxtecan
- Where
- 26 sites in United States, China
- Volunteers
- 800 people
- Sponsor
- Sun Yat-sen University
Advanced Gastroesophageal Adenocarcinoma
RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2
This study was a single-arm, open, multi-center Phase Ib/II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC plus S-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate…
- Trial name
- NCT05403242
- Testing
- RC48-ADC, S-1
- Where
- 3 sites in China
- Volunteers
- 42 people
- Sponsor
- Chinese PLA General Hospital
Breast Cancer
99mTc-ADAPT6-based HER2 Imaging in Breast Cancer
The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are: 1.
- Trial name
- 99mTc-ADAPT6 (NCT03991260)
- Testing
- SPECT
- Where
- Russia
- Volunteers
- 16 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences