Clinical trials: HER2/Neu Positive
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.
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
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
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 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
ER-positive, HER2-negative Breast Cancer
A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833
The Sponsor is developing the test medicine, AZD9833 for the potential treatment of estrogen receptor (ER)-positive breast cancer.
- Trial name
- NCT05364255
- Testing
- [14C]AZD9833 Oral Solution, 75 mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
HER2-positive Breast Cancer
PIK3CA in HER2+ BC and pCR Trial
The goal of the study is to evaluate the impact of somatic PI3KCA mutations on pCR in HER2-positive early breast cancer in real life. The main question it aims to answer iS.
- Trial name
- NCT05750693
- Testing
- PIK3CA analysis
- Where
- Italy
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
HER2-Positive Breast Carcinoma
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
This study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.
- Trial name
- NCT06557057
- Testing
- Non-Interventional Study
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
HER2-positive Metastatic Breast Cancer, Ovarian Cancer
Feasibility of a New Technology for Isolating Circulating Tumour Cells
This is a prospective interventional single-site research with a collection of biological samples. The primary objective of the trial is to assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in…
- Conditions
- HER2-positive Metastatic Breast Cancer, Ovarian Cancer, Hormone-resistant Prostate Cancer, Circulating Tumor Cell
- Trial name
- CTC-SMMiL-E (NCT03979339)
- Testing
- Blood sample collection
- Where
- France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Centre Oscar Lambret
HER2-positive Recurrent / Metastatic Breast Cancer
Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects
The study will assess the effect of anti-diarrhea drug Montmorillonite Power or Loperamide on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects.
- Trial name
- NCT05252546
- Testing
- pyrotinib tablet, Montmorillonite Power, Loperamide
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Muscle-invasive Bladder Urothelial Carcinoma
A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer
This is a prospective, open-label, single-center, single-arm clinical study. Plans to enroll 45 MIBC patients with clinical stage T2-T4aN0M0 and HER2-positive (IHC 1+/2+/3+) status.
- Trial name
- NCT07279597
- Testing
- RC48-ADC + Toripalimab
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Tongji Hospital
Breast Cancer Female
Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
This study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and…
- Trial name
- NCT06035679
- Testing
- Pyrotinib and Trastuzumab
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Youzhi Zhu
HER2-positive Breast Cancer and Gastric Cancer
Clinical Study of 68Ga Labeled HER2 Affibody Analogues
The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 68Ga labeled HER2 Affibody analogues and preliminarily evaluate its diagnosis value in patients with breast…
- Trial name
- NCT05411432
- Testing
- 68Ga labeled HER2 Affibody
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Xijing Hospital
Breast Cancer
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants.
- Trial name
- NCT00800436
- Testing
- Herceptin
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Trastuzumab Cardiotoxicity, HER2-Positive Breast Cancer Survivors
Assessment for Long-Term Cardiovascular Impairment Associated With Trastuzumab Cardiotoxicity in HER2-Positive Breast Cancer Survivors
This is for participants with a history of HER2-positive breast cancer and were treated with chemotherapy that increases the risk of abnormal heart function.
- Trial name
- NCT02615054
- Testing
- 2D Echocardiogram, Cardiopulmonary exercise testing and post-CPET cardiac function
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center