Clinical trials: Trastuzumab
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
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
Healthy Volunteer
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
- Trial name
- NCT02100917
- Testing
- DMB-3111, trastuzumab
- Where
- Japan
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Meiji Seika Pharma Co., Ltd.
Breast Cancer, Breast Neoplasms
A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2).
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Disease, Antineoplastic Agents
- Trial name
- NCT06886659
- Testing
- Trastuzumab (proposed Trastuzumab biosimilar), Herclon
- Where
- 2 sites in Bangladesh
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Incepta Pharmaceuticals Ltd
Healthy
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.
- Trial name
- NCT02075073
- Testing
- SB3, EU sourced Herceptin®, US sourced Herceptin®
- Where
- Germany
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis 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
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
Breast Cancer, Chemotherapeutic Agent Toxicity
Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
RATIONALE: Gathering information over time from laboratory tests, imaging scans, and assessment tests may help doctors learn more about the side effects of chemotherapy and plan the best treatment.
- Conditions
- Breast Cancer, Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Fatigue
- Trial name
- NCT00755313
- Testing
- trastuzumab, aromatase inhibition therapy, carboplatin
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
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
First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects
This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers
- Trial name
- NCT03912441
- Testing
- BCD-147
- Where
- Russia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Biocad
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 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.
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
Health Adult Subjects
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®
The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent…
- Trial name
- NCT07495930
- Testing
- HLX319, EU-Phesgo
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
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
Breast Cancer, Adjuvant Therapy
Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer
To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor…
- Trial name
- NCT05292742
- Testing
- Pyrotinib+Trastuzumab+Capecitabine, Trastuzumab+Pertuzumab/Trastuzumab
- Where
- China
- Volunteers
- 206 people, healthy volunteers welcome
- Sponsor
- Fujian Medical University Union Hospital
Metastatic Breast Cancer, Metastatic Gastric Cancer
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells.
- Trial name
- NCT05765357
- Testing
- Trastuzumab for injection, Herceptin
- Where
- China
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
HER2-positive Breast Cancer
The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.
This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.
- Trial name
- NCT06330012
- Testing
- GeoMx data analysis with clinical outcome
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Healthy Volunteers
Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin
This is a double-blind, two-arm, parallel-group, single-dose study.
- Trial name
- NCT02665637
- Testing
- Trastuzumab
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Celltrion