A phase II study of metronomic oral chemoterapy with Cyclophosphamide plus Capecitabine combined with Trastuzumab in advanced breast cancer - ND

GOIM GRUPPO ONCOLOGICO MERIDIONALE0 个研究点开始时间: 2010年4月9日最近更新: 2012年9月3日

适应症

试验速览

暂无简介。

•Pre- or post-menopausal women with histologically proven, locally advanced (inoperable) or metastatic breast carcinoma. Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. No previous lines of chemotherapy for advanced disease (primary and/or adjuvant chemotherapy are allowed, as well as any prior endocrine treatment; prior primary and/or adjuvant trastuzumab therapy are allowed, if ended  6 months before. At least 4 weeks must have elapsed since prior chemotherapy or radiation therapy, 6 weeks if the last regimen included mitomycin C). Age >18 years and < 80 years. ECOG performance status <2 (Karnofsky >60% Normal organ and marrow function Ability to understand and the willingness to sign a written informed consent document
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Presence of cerebral or leptomeningeal involvement. Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix. History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab or other agents used in the study Seriuos cardiac illness -Poorly controlled hypertension Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, renal failure, or psychiatric illness/social situations that would limit compliance with study requirements.

发起方

GOIM GRUPPO ONCOLOGICO MERIDIONALE