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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
