Clinical trials: HER2
Breast Cancer, HER2-positive Breast Cancer
Investigating the Long-term Cardiac Sequelae of Trastuzumab Therapy
The introduction of trastuzumab for the treatment of patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer has had a major impact upon cancer outcomes.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Cardiotoxicity
- Trial name
- NCT05019365
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Glasgow
Metastatic Breast Cancer
Pyrotinib in Combination With Fulvestrant in Patients With HER2 Positive，HR-Positive Metastatic Breast Cancer
HR+/HER2+（Human epidermal growth factor receptor 2 positive and hormone receptor positive）metastatic breast cancer is a special subtype of HER2+breast cancer.
- Trial name
- NCT04034589
- Testing
- Pyrotinib combined with fulvestrant
- Where
- 2 sites in China
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.
This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with…
- Trial name
- NCT07207070
- Testing
- JS105, Dalpiciclib, Fulvestrant 50 Mg/mL Intramuscular Solution
- Where
- 2 sites in China
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- Risen (Suzhou) Pharma Tech Co., Ltd.
Solid Tumor (Excluding CNS), HER2
68Ga-XHER2 PET/CT for HER2 Assessment
The objective of this study is to evaluate the feasibility of 68Ga-XHER2 PET/CT as a noninvasive imaging approach for assessing HER2 expression in patients with solid tumors and to investigate the correlation between tracer…
- Conditions
- Solid Tumor (Excluding CNS), HER2, PET / CT
- Trial name
- NCT07885436
- Testing
- 68Ga-XHER2 PET/CT
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital of Xiamen University
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
HER2-positive Breast Cancer, HER2 Low
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.
- Conditions
- HER2-positive Breast Cancer, HER2 Low, SYD-985, SYD985
- Trial name
- NCT04602117
- Testing
- Vic-trastuzumab duocarmazine (SYD985) + paclitaxel
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QuantumLeap Healthcare Collaborative
Breast Cancer, Breast Biopsy
Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL
BACKGROUND AND CURRENT STATUS: Advancements in neoadjuvant systemic treatments (NST) for HER2 positive and triple-negative (TN) breast cancer (BC) subtypes have led to high rates of pathologic complete response (pCR), raising…
- Trial name
- BISUCO (NCT06371989)
- Testing
- Image guided vacuum assisted biopsy
- Where
- Spain
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario 12 de Octubre
Urology
Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial
This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS…
- Trial name
- NCT07151560
- Testing
- 6 cycle RC48 and JS001, 12 cycle RC48 and JS001
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Renmin Hospital of Wuhan University
Breast Cancer, Neoplasm, Breast
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and…
- Conditions
- Breast Cancer, Neoplasm, Breast, Breast Diseases
- Trial name
- NCT03756064
- Testing
- Pyrotinib, Trastuzumab, Docetaxel
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Zhejiang Cancer Hospital
HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma
Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
Antibody-drug conjugates (ADCs) have demonstrated substantial improvement in progression free survival (PFS) and overall survival (OS) in phase III clinical trials in patients with metastatic triple negative breast cancer (mTNBC)…
- Conditions
- HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, Metastatic Breast Cancer, HR+ HER2 Breast Cancer
- Trial name
- ENCORE (NCT06774027)
- Testing
- Specimen collection, Non-Investigational Antibody-Drug Conjugates (ADC), Medical Record Review
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Metastatic Breast Cancer
Characterization of Innate Immune System in Patients With Luminal Advanced Breast Cancer
This is a multicentre, prospective, observational, no post-authorization study. This study will be opened for recruitment approximately for 12 months for a pilot phase including at least 25-30 patients and 6 controls and for 12…
- Trial name
- NIKOLE (NCT04370522)
- Where
- 2 sites in Spain
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Spanish Breast Cancer Research Group
Metastatic HR+/HER2- Breast Cancer
Rash & Diarrhea Prophylaxis With Capivasertib
This is a randomized, multicenter, phase II clinical trial evaluating prophylactic strategies to mitigate common toxicities associated with capivasertib in combination with fulvestrant in participants with hormone…
- Trial name
- SAFE-CAP (NCT07426822)
- Testing
- Capivasertib, Loperamide, Fulvestrant
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Maryam Lustberg
Advanced Non-small Cell Lung Cancer, EGFR Mutation
A Study to Learn About How BAY2927088 Affects the Level of Dabigatran or Rosuvastatin in the Blood When These Drugs Are Taken Together in Healthy Participants
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor…
- Conditions
- Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation, Healthy Volunteers
- Trial name
- NCT06329895
- Testing
- BAY2927088, Dabigatran etexilate, Rosuvastatin
- Where
- United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)
In this study, healthy male volunteers will receive a single intravenous administration of either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union).
- Trial name
- NCT01603264
- Testing
- PF-05280014, Herceptin
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer, HER2-positive Breast Cancer
Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1
The purpose of this study is to learn more about how to treat patients with a diagnosis of diagnosis of Human Epidermal Growth Factor Receptor 2/neu (HER-2/neu) positive breast cancer in the past, who were previously treated with…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, HER-2 Gene Amplification, HER2 Positive Breast Carcinoma
- Trial name
- NCT03630809
- Testing
- HER2 DC1 Vaccine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer Female
Impact of Recurrence Score on Adjuvant Treatment Decisions in Breast Cancer Patients
IRMA is a Prospective, monocenter, non-interventional investigator initiated (IIT) registry that aims to investigate the use of the CE-marked OncotypeDX and its impact on adjuvant therapy recommendations in the clinical routine.
- Trial name
- NCT03961880
- Where
- Germany
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen
Breast Cancer Female
Biological Characteristics of Older Women (> 70 Years) With ER Positive, HER2 Negative Early Breast Cancer
This study is investigating the biological characteristics of early oestrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC) in older woman (aged > 70 years) who were treated…
- Trial name
- BOLD-70 (NCT05734950)
- Testing
- Translational study
- Where
- United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Cancer, HER2-negative Breast Cancer
Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer
A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after…
- Trial name
- NCT06375798
- Testing
- radiotherapy
- Where
- China
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- Hebei Medical University Fourth Hospital
Breast Cancer Female
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement.
- Trial name
- CARMEN (NCT07242118)
- Testing
- SABR
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Healthy Volunteers, Breast Cancer
Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.
- Trial name
- CAM-VHH1 (NCT02683083)
- Testing
- [131I]-SGMIB Anti-HER2 VHH1
- Where
- Belgium
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Precirix