Clinical trials: HER2 + Breast Cancer
TNBC - Triple-Negative Breast Cancer
Targeting Metastatic Breast Cancers by Alkaline Glucosodiene Molecules Via a Metabolic Pathway Phase I Clinical Trial
The diverse group of breast tumors known as triple-negative breast cancer (TNBC) which is lethally and deadly type of breast cancer and insensitive to endocrine therapy and HER2-targeted therapy because it lacks the expression of…
- Trial name
- NCT05957939
- Testing
- Alkaline Glucosodiene Molecules
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Saudi Arabia
Healthy
A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and…
- Trial name
- NCT03242239
- Testing
- ALT02, EU-licensed Herceptin, US-licensed Herceptin
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Alteogen, Inc.
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
Breast Cancer Detection, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly.
- Conditions
- Breast Cancer Detection, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Female, Breast Cancer - Ductal Carcinoma in Situ (DCIS)
- Trial name
- NCT07331506
- Testing
- Peripheral blood draw
- Where
- Argentina
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Oncoliq US Inc
Advanced HER2 Negative Breast Carcinoma, HRD+Breast Cancer
Fluzoparib in Combination With Chidamide or Camrelizumab for HRD Positive HER2 Negative Advanced Breast Cancer
This study is planned to include 40 patients with HER2-negative advanced breast cancer to receive fluzoparib combined with chidamide or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of…
- Trial name
- NCT05085626
- Testing
- fluzoparib+chidamide, fluzoparib+camrelizumab
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Healthy Subjects
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
This study will be conducted in healthy post-menopausal female subjects to assess the pharmacokinetics (PK) of Camizestrant (AZD9833) when administered alone and in combination with Itraconazole.
- Trial name
- NCT05551897
- Testing
- Camizestrant, Itraconazole
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
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.
Locally Recurrent and Metastatic Breast Cancer
Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients
This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment…
- Trial name
- NCT00511459
- Testing
- AMG 386, Bevacizumab, Paclitaxel
- Where
- 77 sites in United States, Australia and 11 more
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- Amgen
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
Triple Negative Breast Cancer, HER2-positive Breast Cancer
Programmed Death-Ligand1 Expression in Her-2 Positive and Triple Negative Breast Cancer
Patients with Her-2 positive and triple negative breast cancer who received neoadjuvant chemotherapy will be included in the study.
- Trial name
- NCT05169853
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
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
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
Breastcancer
Immunotherapy Vaccine and Herceptin in Breast Cancer
The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast…
- Trial name
- NCT03014076
- Testing
- GP2 peptide + GM-CSF vaccine plus trastuzumab, Trastuzumab
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cancer Insight, LLC
HER2-positive Breast Cancer
Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer
This study is a one-arm, open, phase II clinical study, and the study subjects are locally advanced and inflammatoryPatients with sexual or early HER2-positive breast cancer entered the trial period after signing informed…
- Trial name
- NCT04481932
- Testing
- Trastuzumab combined with Pyrotinib and chemotherapy
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Peking University
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
Breast Cancer
Study on the Value of Non-invasive Dual-Pet Information in Subtype of Metastatic Breast Cancer
Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer
- Trial name
- NCT04758416
- Testing
- biopsy or surgical pathology in metastases, 68Ga-HER2 affibody,18F-FDG, 18F-FES
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Fudan University
Triple Negative Breast Cancer, HER2-positive Breast Cancer
Exosome as the Prognostic and Predictive Biomarker in EBC Patients
This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients
- Trial name
- NCT05955521
- Testing
- exosome and ctDNA evaluation
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
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
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