Status:
COMPLETED
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 fe...
Eligibility Criteria
Inclusion
- Healthy Participants (Part 1 only)
- Males 18 to 45 to years of age
- Baseline left ventricular ejection fraction (LVEF) greater than (\>) 60 percent (%)
- HER2-Positive Females (Parts 1 and 2)
- Females greater than or equal to (≥) 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0
- Previous non-metastatic operable primary invasive HER2-positive breast cancer
- Baseline LVEF \>55%
Exclusion
- Healthy Participants (Part 1 only)
- Clinically significant abnormalities in laboratory test results or electrocardiogram
- History of significant allergies, gastrointestinal, renal, hepatic, cardiovascular, or pulmonary disease
- History of hypersensitivity or allergic reaction, spontaneous or following drug administration
- History of cardiac conditions
- HER2-Positive Females (Parts 1 and 2)
- Metastatic disease
- Concurrent other malignancy requiring therapy of any modality which may interfere with PK investigations or result in unexpected toxicity
- Use of Herceptin in previous 5 months
- Serious cardiac illness
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00800436
Start Date
November 1 2008
End Date
October 1 2009
Last Update
December 16 2016
Active Locations (3)
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1
East Bentleigh, Australia, VIC 3165
2
Christchurch, New Zealand, 8011
3
Grafton, New Zealand, 1150