None listed
Conditions
Interventions
Patients in this study will be treated with Cofactor (5,10-Methylenetetrahydrofolate), in 100 mg vials, at a dose of 60 mg / m2 / day, administered in an IV bolus infusion, for 2-3 minutes + 5- Fluorouracil, in 10 ml ampoules containing 50 mg / ml of the drug, at a dose of 500 mg / m2 / day, in an IV bolus infusion, for 2-3 minutes, 20 minutes after the Cofactor infusion. This scheme will be administered once a week for 6 weeks, each treatment cycle lasting 8 weeks, until the progression of the
Sponsors
ADVENTRIX PHARMACEUTICALS U.S.A,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent. 2. Women with a histologically / cytologically proven diagnosis of breast adenocarcinoma. 3. Measurable disease. At least one non-bone lesion measurable in a one-dimensional form, with a diameter> 10 mm using computed helical computed tomography or magnetic resonance imaging according to the RECIST criteria. 4. Patients who have failed with both previous chemotherapy regimens with anthracycline and taxane derivatives.
Exclusion criteria
Exclusion criteria: 1. Positive tumor Her2 / neu 2+ or 3+. 2. Pregnancy or lactation. 3. Systemic cytotoxic anticancer therapy, within ≤ 4 weeks of enrollment or 6 weeks if systemic therapy contains a nitrosourea or mitomycin. 4. Previous chemotherapy with 5-FU- and / or palliative chemotherapy based on capecitabine. 5. Extensive prior radiation therapy that affects more than 30% of the bone marrow reserves, or bone marrow / stem cell transplant. 6. Participation in clinical studies of non-approved experimental substances or procedures within ≤ 4 weeks of study enrollment. 7. History of another malignancy, unless the patient is cured and has been free of disease for ≥ 2 years. 8. Previous unforeseen reaction to fluoropyrimidines with or without documented deficiency of dihydropyrimidine dehydrogenase, or a history of hypersensitivity to 5-FU. 9. Psychological, family, sociological or geographical states that do not allow compliance with the protocol of the study and / or the study. 10. Significant heart disease, including symptomatic ventricular arrhythmia, congestive heart failure, myocardial infarction within 12 months prior to enrollment. 11. Concomitant treatment with any experimental drug or anticancer drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical and imaging evaluation (MRI, CT) of the presence or absence of a confirmed objective response. Which is defined as a Complete Response (CR) or a Partial Response (PR), according to the RECIST criteria. Where CR is the disappearance of all target lesions and PR is a 30% decrease in the sum of the larger diameters of the target lesions. Measure:Rate of confirmed objective answers. Timepoints:At the end of each treatment cycle of 8 weeks, at the end of the study and during the follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Determination of the time from the randomization until reaching the Objective Response criteria (determined previously). Criterion 2: Determination of the time elapsed from the entrance to the study to the progression of the disease (according to the RECIST criteria) or death. The progression of the disease is defined as: 1) For white lesions: Increase of 20% in the sum of the larger diameters or the appearance of one or more new lesions. 2) For non-white lesions: Occurrence of one or more new lesions and / or unambiguous progression of the existing lesions. Criterion 3: Determination of the time elapsed from entry into the study to death from any cause. Measure:Secondary efficacy: 1) Target response duration. 2) Free survival of progression (PFS). 3) Total survival. Timepoints:When the requirements for any of the criteria are met. ; Outcome name:Criterion 1: Toxicity will be assessed and classified according to the Common Terminology Criteria for Adverse Events of the NCI - Version 3.0 of the Cancer Therapy Evaluation Program (DCTD - NCI). Criterion 2: Clinical evaluation of all adverse events that generate inability to work or develop normal daily activities. Criterion 3: Determination of the number of patients who discontinue the medication due to some toxicity. Criterion 4: Panels of hematology and serum chemistry, laboratory analysis. Measure:Safety: 1) Incidence and safety of toxicity. 2) Incidence of Serious Adverse Events. 3) Incidence of treatment discontinuation due to toxicity. 4) Laboratory tests. Timepoints:Criteria 1, 2 and 4: Weeks 1-8 of the first cycle and in each subsequent treatment cycle. Criterion 3: When the event is presented. | — |
Countries
Argentina, Mexico, Peru, Russian Federation, Spain
Outcome results
None listed