None listed
Conditions
Interventions
Group 1 Type of group
Daily continuous dosage of 37.5 mg of sunitinib malate
Group name:Group 2 Type of group
1,250 or 1,000 (in patients over 65 years of age) mg / m2 twice a day (Days 1-14) every three weeks of capecitabine.
Sponsors
PFIZER S.A.,
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Histological or cytologically proven diagnosis of breast adenocarcinoma that is not treatable by surgery, radiation or combined modality treatment with curative intent. • Measurable disease according to RECIST. Measurable lesions that have received prior radiation will not be considered objective lesions, unless an increase in their size has been observed after the completion of radiotherapy. • The tumor must be negative HER 2 (immunostaining with value of O or 1+ or negative EISH, in case of having carried out both tests, the results of the FISH study should be used. • They must have received prior treatment with an anthracycline and a taxane, either concurrently or sequentially in the neoadjuvant, adjuvant and / or advanced disease treatment settings. No more than 2 chemotherapeutic regimens are allowed in the advanced setting. • They must have received an adequate course of anthracyclines, considered standard for the treatment of adjuvant and / or metastatic disease, unless consecutive treatment with anthracyclines is not indicated. Prior hormone therapy or immunotherapy is allowed in adjuvant and / or advanced / metastatic disease settings. Immunotherapy should be interrupted at least three weeks before enrollment in the study. Hormone therapy should be stopped before you start the study treatment. • They may have received prior radiation therapy. A measurable lesion that has previously received radiation will not be considered an objective lesion and should only be evaluated when it increases in size. Radiotherapy must be completed before the evaluation of the scrutiny condition. • Female patients, 18 years of age or older. • Performance Status According to the ECOG Scale of 0.1 or 2. • Resolution of all acute toxic effects of previous therapy or surgical procedures to the degree <1 (except alopecia) or other toxicities not considered a risk to patient safety. • Adequate organic function • Signed and dated informed consent document stating that the patient (or their legally acceptable representative) has been informed about all relevant aspects of the study prior to recruitment. • Availability and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
Exclusion criteria
Exclusion criteria: • More than 2 previous chemotherapy regimens in advanced / metastatic disease setting and any previous regimen containing capecitabine. • Major surgery, or systemic treatment (except hormone therapy) within three weeks of the first study treatment. At least seven days should elapse from the time of the minor surgical procedure, including placement of an access device or fine-needle aspiration prior to randomization in this study. • Wounds that have not healed completely, active ulcer (s) or bone fracture (s). • Current treatment in another clinical study. • Brain metastases, compression of the spinal cord or carcinomatous meningitis or leptomeningeal disease. • Bone lesions as the only manifestation of current metastatic breast cancer. • Diagnosis of any second malignancy within the last three years, except previous breast cancer, adequately treated basal cell or spinocellular skin cancer, or carcinoma in situ of the cervix. • Any of the following within the 6 months prior to the start of treatment under study: myocardial infarction, severe / unstable angina, congestive heart failure, stroke, including transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic events . • Cardiac arrhythmias in the course of NCICTCAE grade> 2, atrial fibrillation of any degree or QTc interval> 470 msg in women. • Hypertension that can not be controlled with medication (> 150/100 mmHg despite optimal medical treatment). • Current treatment with therapeutic doses of coumarin derivatives or oral vitamin K antagonists such as warfarin and Fenprocoumon (the use of low doses is allowed for the prophylaxis of deep vein thrombosis). If patients are receiving treatment with these agents, their TP or JNR should be monitored. Low molecular weight heparin is allowed at any dose. • Known infection with human immunodeficiency virus, as well as patients with active Hepatitis B and C infection. Active infection is defined when patients require treatment. • Patients who are pregnant or breastfeeding, patients who are likely to become pregnant or are not willing or who are unable to use adequate contraception to avoid pregnancy during the program. All patients with a chance of getting pregnant should have a negative pregnancy test (serum or urinary) before the first day of the study medication. • Other acute or severe chronic or medical or psychiatric disorder or a laboratory abnormality that could represent, in the investigator´s judgment, an excessive risk associated with participation in the study or with the administration of the study drug, or that, at the discretion of the researcher, could make the patient inadequate to enter this study. • History of severe and unexpected reactions to treatment with fluoropyrimidine or known hypersensitivity to 5-fluorouracil or capecitabine or to any of the excipients of capecitabine. • Known deficiency of dihydropyrimidine dehydrogenase. • Current treatment with sorivudine or its chemically related analogues, such as brivudine • Previous treatment with anti-angiogenic therapy including the inhibitors of tyrosine kinases with multidirected action, such as sorafenib or agents in the experimental stage. Prior treatment with bevacizumab will be allowed. • Pre-existing thyroid abnormality with thyroid function that can not be conserved within normal limits. • Previous treatment with TS-1 (tegaflir / gimeracil /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as Survival Without Progression (PFS) at the time from randomization to the first documentation of objective tumor progression or until death due to any cause, whichever occurs first. Measure:Comparison of Survival without Progression (PFS) curves between the two treatment groups Timepoints:Until death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the time from randomization to the first documentation of objective tumor progression. Measure:Time for Tumor Progression (TTP) Timepoints:During the study ; Outcome name:Defined as the time from randomization to the first documentation of death due to any cause. Measure:Global Survival (OS) Timepoints:Until the first documentation of death due to any cause. ; Outcome name:Defined as the time from the first documentation of GR (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or death due to any cause. Measure:Duration of the Response (DR) Timepoints:During the study ; Outcome name:Defined as the percentage of patients with confirmed CR or PR confirmed according to the RECIST system, in relation to the total analysis population. The confirmed answers are those that persist in the repeated imaging study> 4 weeks after the initial documentation of the response. Measure:Objective response (OR) Timepoints:During the study | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, France, Germany, India, Italy, Japan, Korea South, Mexico, Philippines, Singapore, South Africa, Spain, Taiwan, Turkey, United Kindgdom
Contacts
Public ContactMilay luis
PFIZER S.A.
Outcome results
None listed