None listed
Conditions
Interventions
Group 1 Type of group
Patients randomized to the treatment arm with RPR109881 will receive an initial dose of 90 mg / m2 IV RPR109881 on Day 1 of Cycle 1 administered for 1 hour, with the exception of patients with documented bone marrow involvement, who will receive a dose initial 75 mg / m2 IV of RPR109881. The treatments will be repeated in the same way at 3-week intervals (3-week cycles). The dose adjustments will be modified
Group name:Group 2 Type of group
Patients randomized to the treatment arm with
capecitabine will receive an initial dose of 1250 mg / m2 of capecitabine tablets to be administered orally twice a day (in the morning and evening, equivalent to a total daily dose of 2500 mg / m2) for 2 weeks followed by a rest period of 1 week, until forming a 3-week cycle.
Sponsors
AVENTIS PHARMA S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diagnosis of histologically or cytologically proven breast adenocarcinoma currently metastatic (TxNxMI) or locally recurrent and inoperable with attempted cure. 2) All patients must have received an anthracycline and a taxane before entering the protocol. 3) Patients must have completed all previous chemotherapy treatments. 4) Evidence of measurable disease according to the definition of the Evaluation Criteria of the Response in Solid Tumors (RECIBI). 5) Male or female patients at least 18 years of age. 6) ECOG Performance Status (Eastern Cooperative Oncology Group) of 0.1, or 2. 7) Patients must have resolved all the clinically significant toxic effects of any surgery, radiotherapy, cryotherapy, chemoembolization therapy, hormone therapy, immunotherapy. 8) Adequate organic functioning. 9) Patients must be postmenopausal, must have been surgically sterilized or must be using an effective contraceptive method. 10) Patients (or their authorized legal representative) must agree to, sign and date an informed consent form. 11) Patients must be willing and able to comply with planned visits, treatment plans, laboratory tests and other study procedures.
Exclusion criteria
Exclusion criteria: 1) History of any second malignancy with the exception of skin cancer of basal cells or squamous cells adequately treated, or carcinoma in situ of the cervix. 2) A history of grade 3 hypersensitivity to taxanes, pyloropyrimidines, Polysorbate-80 or to compounds with similar chemical structures. 3) The following treatments for breast cancer: Patients receiving> 1 adjuvant regimen, Patients receiving> 1 regimen of chemotherapy for breast cancer] mechastatic or relapse and Inoperable. 4) Previous treatment with capecitabine or any analogue of taxanes. 5) Concomitant treatment with potent cytochrome P450 3A4 inhibitors. 6) Concomitant treatment in another clinical study or with any other treatment for cancer that includes chemotherapy, immunotherapy, hormone therapy, radiotherapy, chemoembolization therapy, cryotherapy. 7) Concomitant treatment with trastuzumab [Herceptin®] is not allowed. 8) Known cerebral or leptomeningeal disease. 9) Any of the following conditions within the 6 months prior to randomization: myocardial infarction, severe / unstable angina, peripheral or coronary artery bypass graft surgery, clinically significant or cardiac arrhythmias. 10) History of inflammatory bowel disease or chronic diarrhea. 11) Peripheral neuropathy grade> 2. 12) Another severe acute or chronic psychiatric or clinical condition, or abnormal laboratory significant values.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:RECIST criteria evaluated by an Independent Review Committee (CRI) Measure:Efficacy of RPR109881 Timepoints:The evaluations are made on days 1, 8, 15 and at the end of each cycle (Each cycle lasts 21 days). In addition to an evaluation on day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:SG: Clinical evaluation. IUTP: RECIST criteria IR: RESCIST criteria Measure:Global Survival (SG): Time from randomization to death. Unique index of time elapsed until progression (IUTP). Response rate (IR) Timepoints:SG, IR: Determined in each periodic evaluation: 1, 8, 15 and at the end of each cycle (Each cycle lasts 21 days). IUTP: Day 120 | — |
Countries
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Gabon, Germany, Greece, Ireland, Italy, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Paraguar, Peru, Portugal, South Africa, Spain, Surinam, Sweden, Switzerland, United Kindgdom, United States
Outcome results
None listed