Clinical trials: Trastuzumab
HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer
Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer
This phase II trial studies how well copper Cu64-DOTA-trastuzumab positron emission tomography (PET) works in predicting response to treatment with trastuzumab and pertuzumab before surgery in patients with human epidermal growth…
- Conditions
- HER2 Positive Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Trial name
- NCT02827877
- Testing
- Copper Cu 64-DOTA-Trastuzumab, Laboratory Biomarker Analysis, Pertuzumab
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- City of Hope Medical Center
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.
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 Male Subjects
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and…
- Trial name
- NCT05275010
- Testing
- Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC), Handheld Syringe with Hypodermic Needle, On-Body Delivery System
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche