Status:
COMPLETED
A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel fo...
Eligibility Criteria
Inclusion
- Adult women greater than or equal to (≥) 18 years of age
- Non-metastatic primary invasive adenocarcinoma of the breast clinical stage I to IIIC, including inflammatory and multicentric/multifocal breast cancer, with tumor size ≥1 centimeter (cm) by ultrasound or ≥2 cm by palpation, centrally confirmed HER2-positive (immunohistochemical score \[IHC\] 3+ or in situ hybridization \[ISH\]-positive)
- At least 1 measurable lesion in breast or lymph nodes (≥1 cm by ultrasound or ≥2 cm by palpation), except for inflammatory carcinoma (T4d)
- Baseline left ventricular ejection fraction (LVEF) ≥55%
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Adequate organ function at Baseline
Exclusion
- History of any prior (ipsilateral 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
Key Trial Info
Start Date :
October 16 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2017
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT00950300
Start Date
October 16 2009
End Date
January 24 2017
Last Update
January 23 2018
Active Locations (106)
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1
Centro Medico San Roque; Oncology Dept
San Miguel de Tucumán, Argentina, T4000IAK
2
Caipo; Oncology
San Miguel de Tucumán, Argentina, T400IAK
3
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil, 41253-190
4
Hospital das Clinicas - UFPR; Quimioterapia
Curitiba, Paraná, Brazil, 80060-900