Trastuzumab
Drug600 mg SC Q3W by SID
Other names: Herceptin
NCT Number: NCT02040935
This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant).
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Medisch Centrum Alkmaar, Alkmaar, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
600 mg SC Q3W by SID
Other names: Herceptin
Time frame: From Baseline up to approximately 4 years
Time frame: Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days)
Time frame: Cycles 3 and 9 (cycle length=21 days)
Time frame: Cycles 3 and 9 (cycle length=21 days)
Time frame: Cycle 6 (cycle length=21 days)
Hoffmann-La Roche
Industry
HOMERUS: A Local, Open Label, Multicentre, Phase IIIB Study, Investigating Subcutaneous Trastuzumab Administered at Home With Single Injection Device in Patients With HER2-Positive Early Breast Cancer
Acronym: HOMERUS
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.
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