Metastatic breast cancer
Conditions
Interventions
Product Name: GEMZAR
Pharmaceutical Form: Powder for infusion*
Product Name: Carboplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Carboplatin
Other descriptive
Sponsors
Southampton University Hospitals NHS Trust
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to measure Overall Response Rate (ORR) in patients treated with a combination of gemcitabine plus carboplatin in a dose dense schedule. Patients will have advanced metastatic breast cancer and have been pretreated with anthracyclines and taxanes. ;Secondary Objective: The secondary objectives of this study are to assess: 1. Overall toxicity 2. Overall survival 3. Time to Disease Progression 4. Duraton of Response 5. Time to Treatment Failure ;Primary end point(s): Overall response rate | — |
Countries
United Kingdom
Outcome results
None listed