None listed
Conditions
Interventions
Patients in this study will be treated with Lapatinib, in 250 mg tablets, at a dose of 1250 mg / day, the dose can be adjusted according to clinical evaluation. + Capecitabine, in 150 mg tablets, at a dose of 2000 mg / m2 / day. The tablets will be taken orally, QD, on days 1 to 14, every 21 days until the patient experiences a progression of the disease or is removed from the study due to unacceptable toxicity or other reasons.
Sponsors
GLAXOSMITHKLINE RESEARCH TRIANGLE PARK,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sign an informed consent. 2. The patient should not be eligible to participate in another clinical trial with lapatinib. 3. Patients will not have received previous treatment with lapatinib in another clinical trial. 4. Prior treatment with hormone therapy is allowed. 5. Patients should have advanced or metastatic breast cancer with progression. 6. Patients should have tumors that overexpress ErbB2. 7. Patients must be ≥18 years. 8. Patients should have a general status according to ECOG between 0 and 2. 9. The life expectancy should be> 8 weeks 10. Patients should have recovered or stabilized enough of the side effects associated with previous treatments. 11. Patients with metastases in the central nervous system will be eligible. 12. The cardiac ejection fraction will be within the range of the normality of the institution measured by echocardiogram. 13. Patients will not be taking any medication listed in the prohibited medications section. 14. The patient should be able to swallow and retain oral medications 15. Patients must complete all screening evaluations indicated in the protocol. 16. Patients should have adequate hematologic, hepatic and renal function.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breast-feeding. 2. Malabsorption syndrome, a disease that significantly affects gastrointestinal function or the removal of the stomach or small intestine. 3. Concurrent illness or condition that does not allow the patient to participate in the study or any serious medical condition that could interfere with the patient´s safety. 4. Severe unresolved or unstable toxicity caused by previous administration of another experimental drug and / or previous treatment against cancer. 5. Infection not controlled. 6. Dementia, altered mental status or any psychiatric condition that does not allow the patient to understand or give informed consent. 7. Active heart disease. 8. Patients receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological therapy or hormonal therapy for the treatment of their cancer. 9. History of allergic reactions attributed to compounds with a chemical composition similar to lapatinib or any of its excipients. 10. History of allergic reactions attributed to compounds with a chemical composition similar to capecitabine, fluorouracil and any of its excipients. 11. Known deficiency of dihydropyrimidine dehydrogenase.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Determination of the time elapsed from randomization to: a) Increase of at least 20% in the sum of the largest diameters of the target lesions. b) Appearance of one or more of a new injury and / or unambiguous progression of existing non-target injuries. Measure:1) Survival without progression (SSP). 2) Global survival. Timepoints:Every 6 weeks during the first six months of the study, and then every 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Clinical evaluation of any unexpected medical event in a patient or in a clinical research subject, temporarily associated with the use of study medication. Criterion 2: Complete physical examination of all organs and systems. Criterion 3: The general condition according to ECOG, qualifies the patient s activity on a scale of 0 to 5. Criterion 4: Blood pressure and pulse after the patient remains seated for five minutes, body temperature and body weight. Criterion 5: Determination of the need for new medications or increase of the dose of current medications to control the symptoms of the disease. Criterion 6: Panels of hematology and serum chemistry. Criterion 7: Standard echocardiogram or a MUGA if the echocardiogram can not be performed or in the case of inconclusive FEV1. Measure:Security: 1) Adverse events. 2) Physical examination. 3) General condition. 4) Vital signs. 5) Concomitant medications. 6) Laboratory tests. 7) Echocardiogram. Timepoints:Day 1, every 3 weeks and after the first 6 weeks, evaluations can be done every 6 weeks. | — |
Countries
Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Bulgaria, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Iceland, Indonesia, Ireland, Israel, Italy, Korea South, Latovia, Luxembourg, Malasya, MAlta, Mexico, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kindgdom, United States, Venezuela
Outcome results
None listed