Status:
COMPLETED
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early bre...
Eligibility Criteria
Inclusion
- Histologically confirmed HER2-positive primary breast cancer
- No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neo-adjuvant or adjuvant)
- Completed neo-adjuvant chemotherapy prior to entry, if received
- At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV Herceptin
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion
- History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or other curatively treated malignancies of which the participant has been disease-free for at least 5 years
- Inadequate bone marrow function
- Impaired liver function
- Inadequate renal function
- Serious cardiovascular disease
- Human immunodeficiency virus or hepatitis B or C infection
- Prior maximum cumulative dose of doxorubicin greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or equivalent
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT01401166
Start Date
October 1 2011
End Date
December 1 2015
Last Update
March 6 2017
Active Locations (75)
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1
Barrie, Ontario, Canada, L4M 6M2
2
Brampton, Ontario, Canada, L6R 3J7
3
Kitchener, Ontario, Canada, N2G 1G3
4
Sault Ste. Marie, Ontario, Canada, P6A 2C4