A Randomized Open-label Study to Compare the Pharmacokinetics, Efficacy and Safety of Subcutaneous (SC) Herceptin (Trastuzumab) With Intravenous (IV) Herceptin (Trastuzumab) Administered in Women With HER2-positive Early Breast Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Randomized Open-label Study to Compare the Pharmacokinetics, Efficacy and Safety of Subcutaneous (SC) Herceptin (Trastuzumab) With Intravenous (IV) Herceptin (Trastuzumab) Administered in Women With HER2-positive Early Breast Cancer
Inclusion Criteria:
- Adult women >/= 18 years of age
- Non-metastatic primary invasive adenocarcinoma of the breast clinical stage I-IIIC,
including inflammatory and multicentric breast cancer, tumour size >/= 1 cm,
histologically confirmed, HER2-positive
- At least 1 measurable lesion in breast or lymph nodes according to RECIST v1.0
criteria, except for inflammatory carcinoma
- Baseline LVEF >/= 55%
Exclusion Criteria:
- History of any prior (ipsi- and/or contralateral) invasive breast carcinoma
- Past or current history of malignant neoplasms, except for curatively treated basal
and squamous cell carcinoma of the skin and in situ carcinoma of the cervix
- Metastatic disease
- Any prior therapy with anthracyclines
- Prior anti-HER2 therapy or biologic or immunotherapy
- Serious cardiac illness
- Pregnant or lactating women
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Trastuzumab serum concentrations, comparing sc versus iv administration
Outcome Time Frame:
throughout cycles 1 to 8
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Hong Kong: Department of Health
Study ID:
BO22227
NCT ID:
NCT00950300
Start Date:
October 2009
Completion Date:
January 2017
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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