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A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
- Cancer
- Breast Cancer
- Breast Cancer HER-2 Positive
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Countries
- Albania
- Algeria
- Argentina
- Australia
- Bosnia and Herzegovina
- Brazil
- Bulgaria
- Canada
- Chile
- Colombia
- Croatia
- Czechia
- Dominican Republic
- Ecuador
- Egypt
- France
- Germany
- Greece
- Guatemala
- Hong Kong
- Hungary
- indonesia
- Ireland
- Italy
- Lithuania
- Malaysia
- Mexico
- Morocco
- Netherlands
- New Zealand
- Norway
- pakistan
- Panama
- Peru
- Philippines
- Poland
- Portugal
- Romania
- Russia
- Saudi Arabia
- Serbia
- Singapore
- Slovakia
- Slovenia
- South Africa
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Thailand
- Turkey
- Ukraine
- United Arab Emirates
- United Kingdom
- United States
- Uruguay
- venezuela
- Vietnam
Trial Identifier:
NCT01566721 2011-005328-17 MO28048
Trial Summary
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01566721,MO28048,2011-005328-17
Trial Identifier
Herceptin
Treatments
Breast Neoplasms
Condition
Official Title
A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%
Exclusion Criteria
- Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
- History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
- Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
- Metastatic disease
- Inadequate bone marrow, hepatic, or renal function
- Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- History of severe allergic or immunological reactions, such as difficult-to-control asthma
- Pregnant or lactating women
For the latest version of this information please go to www.forpatients.roche.com