Clinical trials: Trastuzumab
Early Breast Cancer
A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)
This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta.
- Trial name
- NCT02738970
- Testing
- Trastuzumab, Pertuzumab
- Where
- 2 sites in New Zealand
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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
Healthy Volunteers
A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects
The purpose of the study is to demonstrate demonstrate the pharmacokinetic (PK) similarity of HD201 to the European (EU) and American (US) reference products Herceptin, following a single i.v.
- Trial name
- TROIKA-1 (NCT03776240)
- Testing
- HD201, EU-Herceptin, US-Herceptin
- Where
- Australia
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Prestige Biopharma Limited
Healthy
To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)
A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects
- Trial name
- NCT06687928
- Testing
- CT-P6 SC, EU-Approved Herceptin SC
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy Volunteers
Pharmacokinetic, Safety and Immunogenicity Study of CMAB809 and Herceptin in Healthy Volunteers
This is a randomized, double-blinded, controlled Phase I study of CMAB809 administered by intravenous infusion. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB809 versus Trastuzumab(Herceptin)…
- Trial name
- NCT04049409
- Testing
- CMAB809, Trastuzumab
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
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
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer
This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally…
- Trial name
- NCT03847818
- Testing
- Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Shandong University
Breast Cancer Model, Effects of Chemotherapy
PERS Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer
This study aims to explore new PERS prediction model can improve the pathological complete response rate of neoadjuvant chemotherapy of breast cancer and disease-free survival.
- Conditions
- Breast Cancer Model, Effects of Chemotherapy, Breast Cancer
- Trial name
- PERS (NCT03006614)
- Testing
- NVB, EPI, DDP
- Where
- China
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Shi Yanxia
Healthy Participants
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
This two-part study will evaluate the bioequivalence, safety, and tolerability of a single SC dose of trastuzumab administered via handheld syringe/syringe pump (HHS/SP) with infusion set (IS) and an on-body delivery system…
- Trial name
- NCT07214766
- Testing
- Trastuzumab
- Where
- 4 sites in United States
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Metastatic Breast Cancer
Clinical Trial of Comparative Study of GB221 Pharmacokinetics
The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg.
- Trial name
- NCT04175171
- Testing
- Coprelotamab Injection, Trastuzumab Injection
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Genor Biopharma Co., Ltd.
Breast Cancer
Gut Microbiome Components Predict Response to Neoadjuvant Therapy in HER2-positive Breast Cancer Patients : A Prospective Study
In this study the characteristics and alterations of the gut microbiome during neoadjuvant therapy for HER2-positive breast cancer patients are studied, as well as the relation between the gut microbiome and probability of pCR.
- Trial name
- NCT05444647
- Testing
- stool and blood collection
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer
Identifying Patterns in the Breath of Individuals With Breast Cancer
Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection.
- Trial name
- NCT06512350
- Where
- 5 sites in United States, Canada
- Volunteers
- 5,175 people, healthy volunteers welcome
- Sponsor
- Breathe BioMedical Inc
Healthy
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects
Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and German).
- Trial name
- NCT02581748
- Testing
- HLX02, Herceptin
- Where
- China
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy
A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)
This study is to prove that there is no difference in the number of healthy male volunteers that will experience pyrexia (i.e. fever with body temperature of 38°C or higher) within a 24 hour period after administration of a…
- Trial name
- NCT02015156
- Testing
- PF-05280014, Herceptin®
- Where
- 2 sites in United States
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer
Study of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction
The main clinical goal of NAC is to down-stage the primary tumor for BCS,yet BCS after NAC has been associated with significantly higher ipsilateral breast tumor recurrences.The accuracy of breast tumor excision in BCS can…
- Trial name
- BCSMANC (NCT01917578)
- Testing
- Ultrasound, CNB, BCS, Modified Radical Mastectomy
- Where
- China
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Shandong Cancer Hospital and Institute
Breast Cancer
Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®
This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in…
- Trial name
- NCT04905667
- Testing
- GB221, Herceptin
- Where
- China
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Genor Biopharma Co., Ltd.
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
Healthy
A Pharmacokinetic Study Comparing EG12014 and Herceptin (Trastuzumab) in Healthy Male Volunteers
The primary objective of this trial is to assess the pharmacokinetic similarity of EG12014 (Test IMP) compared to reference products sourced from the European Union (Reference IMP 1: Herceptin® 150 mg powder for concentrate for…
- Trial name
- NCT03180242
- Testing
- EG12014, EU-sourced Herceptin, US-sourced Herceptin
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- EirGenix, Inc.
Healthy
Phase 1 Study of Trastuzumab Administered as a Single Intravenous Infusion
The primary objective of this study was to demonstrate pharmacokinetic similarity of Mylan trastuzumab (Hercules) versus EU-approved Herceptin® and US-licensed Herceptin® and pharmacokinetic similarity of EU-approved Herceptin®…
- Trial name
- NCT02594761
- Testing
- Hercules, Herceptin EU, Herceptin US
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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