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
- Conditions
- Metastatic breast cancer
- Registration Number
- EUCTR2005-005164-83-GB
- Lead Sponsor
- Southampton University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 35
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method