EUCTR2010-024099-25-GBActive, not recruitingPhase 1
A randomized, multi-center cross-over study to evaluate patient preference and Health Care Professional (HCP) satisfaction with subcutaneous (SC) administration of trastuzumab in HER2-positive early breast cancer (EBC) - PrefHer Study
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •- Female patients, >/= 18 years of age
- •- HER2-positive breast cancer
- •- No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy (neoadjuvant or adjuvant)
- •- All (neo)adjuvant chemotherapy must be completed, adjuvant radiotherapy may be ongoing
- •- Patients who have already received IV Herceptin must have at least 8 out of the total planned 18 3-week cycles remaining
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
- •- History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix or basal cell carcinoma, or other curatively treated malignancies that have been disease-free for at least 5 years
- •- Inadequate bone marrow function
- •- Impaired liver function
- •- Inadequate renal function
- •- Serious cardio-vascular disease
- •- HIV or hepatitis B (HBV) or C (HCV) infection
- •- Prior maximum cumulative dose of doxorubicin > 360 mg/m2 or epirubicin > 720 mg/m2 or equivalent
Investigators
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