A PHASE 2 STUDY OF CARBOPLATIN IN COMBINATION WITH GEMCITABINE AS A DOSE DENSE SCHEDULE IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER THAT ARE RESISTANT TO ANTHRACYCLINES & TAXANES. - Gem Carbo in breast cancer

Southampton University Hospitals NHS Trust0 个研究点目标入组 35 人开始时间: 2006年4月10日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Patients > 18 years with histologically proven breast cancer and a diagnosis of locally advanced/or metastatic breast cancer. Where there is a solitary site of recurrence, histological or cytological confirmation is required. Males are eligible.
•2.Patients must have received prior treatment with an anthracycline and a taxane either as neoadjuvant, adjuvant or metastatic therapy.
•4.Patients must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 2.0 cm with conventional techniques or as ? 1.0 cm with spiral CT scan. Palpable disease is acceptable.
•8.Estimated life expectancy of at least 12 weeks.
•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) no
•F.1.3.1 Number of subjects for this age range

•2.Pregnant or breast-feeding.
•5.Prior treatment with Gemcitabine, cisplatin or carboplatin.
•6.Patients with only non-measurable disease, defined as all other lesions, including small lesions (longest diameter <2.0 cm with conventional techniques or <1.0 cm with spiral CT scan) and truly non-measurable lesions, which include the following: bone lesions; leptomeningeal disease; ascites; pleural/pericardial effusion; inflammatory breast disease; lymphangitic pulmonary disease; abdominal masses that are not confirmed and followed by imaging techniques; cystic lesions.
•7.Receiving concomitant anticancer treatment.
•8.Have received cytotoxic chemotherapy in the 21 days prior to study entry.

发起方

Southampton University Hospitals NHS Trust