Trastuzumab
DrugTrastuzumab IV or SC will be administered as described.
Other names: Herceptin
NCT Number: NCT02194166
This multicenter study in participants with HER2-positive eBC will investigate participants' pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual administration using a hand-held syringe (SC vial). In total, participants will obtain at least 18 cycles/1 year of trastuzumab (4 cycles of intravenous [IV] and 14 cycles of SC trastuzumab).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology, A/g Lesnoy, Minsk Region, Belarus
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Trastuzumab IV or SC will be administered as described.
Other names: Herceptin
Paclitaxel will be administered in accordance with local hospital practice.
Docetaxel will be administered in accordance with local hospital practice.
Time frame: Week 13 up to Week 52
Time frame: Week 13 up to Week 52
Time frame: Week 22
Time frame: Week 52
Time frame: Week 22
Time frame: Baseline up to approximately 3 years
Time frame: From first study treatment to death from any cause, assessed up to approximately 4.5 years
Time frame: From first study treatment to documented disease progression or death, assessed up to approximately 3 years
Time frame: Week 1 up to Week 52
Time frame: Week 1 up to Week 52
Time frame: Week 1 up to Week 52
Time frame: Week 1 up to Week 52
Time frame: 28 days after last study treatment (up to Week 56)
Time frame: 25 months after last study treatment (up to 3 years)
Hoffmann-La Roche
Industry
An Open-Label, Randomized, Cross-Over, Multicenter, Phase IIIb Study, to Assess Patients' Tolerability of Trastuzumab Administrated Subcutaneously (SC) Either Via a Single Use Injection Device (SID) or Via Vial for Manual Administration (SC Vial) in Patients With HER2-Positive Early Breast Cancer (eBC)
Acronym: ESCAPE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT05754658
Breast Cancer, Breast Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT07040514
Breast Cancer, Breast Diseases
Lebanon, New Hampshire, United States
View Trial DetailsNCT06604858
Breast Cancer, Breast Diseases
A Coruña, Spain
View Trial Details