Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Samsung Bioepis Co., Ltd.
Age
18–65
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Female aged 18-65 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Non-metastatic, unilateral newly diagnosed primary breast cancer of clinical stage II to III including inflammatory breast cancer with:
1. tumour size ≥ 2 cm
2. histologically confirmed primary invasive carcinoma of the breast
3. HER2-positivity confirmed by a central laboratory or an accredited local laboratory and defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+
Known hormone receptor (oestrogen receptor and progesterone receptor) status
Baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography or multiple gated acquisition (MUGA) scan
Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures
You may not be if
Metastatic (stage IV) or bilateral or multifocal/multicentric breast cancer
History of any prior invasive breast carcinoma, except for subjects with a past history of ductal carcinoma in situ (DCIS) and/or lobular carcinoma in situ (LCIS) treated with surgery only
Past or current history of malignant neoplasms within 5 years prior to Randomisation, except for curatively treated carcinoma in situ of uterine cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin (malignant neoplasms occurring more than 5 years prior to Randomisation are permitted if curatively treated with surgery only)
Previous history of radiation therapy, immunotherapy, chemotherapy or biotherapy (including prior HER2 directed therapy) Major surgery within 4 weeks prior to Randomisation and minor surgery within 2 weeks prior to Randomisation (major surgery is defined as surgery which requires general anaesthesia)
Serious cardiac illness that would preclude the use of trastuzumab such as:
1. history of documented congestive heart failure (CHF) (New York Heart Association, NYHA, class II or greater heart disease)
Serious pulmonary illness enough to cause dyspnoea at rest or requiring supplementary oxygen therapy
Known history of hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection
Other concurrent serious illnesses that may interfere with planned therapy including severe cardiovascular, pulmonary, metabolic or infectious conditions
Known hypersensitivity to the investigational product (IPs), non-IPs or any of the ingredients or excipients of the IPs or non-IPs
Known hypersensitivity to murine proteins
Known history of dihydropyrimidine dehydrogenase (DPD) deficiency
Pre-existing peripheral sensory or motor neuropathy ≥ grade 2, defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0
Pregnant or lactating women. A pregnancy test result is required for all women of childbearing potential including women who had menopause onset within 2 years prior to Randomisation. Women of childbearing potential must agree to use contraceptive methods (see section 7.4.2) during the study and 6 months after the last dose of IP
Concurrent hormonal therapy including birth control pills, ovarian hormone replacement for menopause, selective oestrogen receptor modulator (SERM) either for osteoporosis or breast cancer prevention
Subjects unwilling to follow the study requirements
