None listed
Conditions
Interventions
Group 1 Type of group
The starting dose of capecitabine is 2000 mg/m2/day, to be divided and given twice daily orally, 12 hours apart, for 14 days, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.
Group name:Group 3 Type of group
The starting dose of gemcitabine is 1000mg/m2/ IV days 1 and 8, every 21 days. A daily dose of Lapatinib is 5 tablets (1250 mg of Lapatinib) taken approximately at the same time each day.
Sponsors
Grupo Latinoamericano de Investigaciones Clinicas en Oncologica (GLICO),
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • The signed informed consent must be obtained in accordance with the requirements of the ethics committee. • Subjects must be over 18 years. • Histologically confirmed invasive adenocarcinoma of the breast with metastatic or locally advanced disease defined as stage IIIb, lile stage with T4 lesion, or stage IV [according to the 6th AJCC edition]. • Documented progression after taxane-based treatment for patients with ErbB2 positive metastatic breast cancer for first-line or locally advanced or documented progression after taxane-based regimens as adjuvant therapy. Patients may have had a maximum prior treatment with a chemotherapy regimen for metastatic disease. • Patients must have at least 1 definite lesion measurable by RECIST as follows: X-ray, physical examination> 20 mm, Conventional CT scan> 20 mm, Spiral CT scan> 10 mm. Measurable lesions should be outside the field of prior radiotherapy if they are in one place of disease. • Disease with over-expression and / or amplification of HER2 / neu confirmed in the local laboratory in the invasive component of the primary or metastatic lesion • Previous therapy should include taxane regime. • In regions where trastuzumab is available without access barriers, patients must also have received trastuzumab alone or in combination with chemotherapy • Previous treatment with anthracyclines in adjuvant / neoadjuvant or metastatic first-line scenarios is allowed if therapy has been discontinued at least 4 weeks before randomization, and all adverse events related to treatment are 50% and in the normal institutional range demonstrated by echocardiogram or alternatively by MUGA Tomography betwe
Exclusion criteria
Exclusion criteria: • Pregnant or nursing women. • Previous therapy with another antiErbb1 or antiErbB2 white agent instead of Trastuzumab only limited by the treatment of V line of metastatic or locally advanced disease OR as adjuvant therapy. • Previous exposure to gemcitabine, Vinorelbine and capecitabine for treatment of 1st line of metastatic-recurrent disease OR as adjuvant / neoadjuvant therapy. • Treatment in the 14 days prior to randomization with anti-cancer therapy (tumor embolization, chemotherapy, immunotherapy, biological therapy, or hormonal therapy) or mitomycin treatment in the 6 weeks prior to randomization. Such treatment may or may not be resumed after admission to the study. Note: Patients receiving bisphosphonate therapy prior to randomization may continue during their participation in the study, however, bisphosphonates should be initiated following study entry. Prophylactic use of bisphosphonates in subjects without bone disease is not allowed, except for the treatment of osteoporosis. • Metastasis in active CNS. • Uncontrolled intercurrent disease including, but not limited to, an infection at that time or active, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, serious wound / ulcer / bone fracture that is not cured, or social situations / psychiatric illnesses that may limit the study requirements. • Patients with Gi tract disease who are unable to take oral medication, malabsorption syndrome, require EV feeding, previous surgical procedures that affect absorption, uncontrolled inflammatory GI disease (eg, Crohn, ulcerative colitis). • Have active liver or biliary disease (with the exception of patients with Gilbert´s syndrome, asymptomatic gallbladder stones, liver metastases or chronic stable liver disease in the investigator´s evaluation). • History of another cancer. Subjects who have been disease free for 5 years, or subjects with a history of skin cancer without completely resected melanoma or successfully treated carcinoma in situ are eligible. • Dementia, altered mental state, or any physical condition that could prohibit the understanding or signing of informed consent. • Concurrent treatment with a research agent or participation in another clinical trial. • Use of research drug in 30 days or half-life preceding the first dose of therapy. • History of immediate or delayed hypersensitivity or idiosyncrasy to drugs chemically related to Lapatinib or navebumin or capecitabine or gemcitabine and its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:CBR is defined as the sum of the complete response (CR) + the partial response (PR) plus disease stabilization (SD) for at least 24 weeks (CR + PR + SD for> 24 weeks), according to the RECIST criteria Measure:Clinical Benefit Rate (CBR) Timepoints:24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the interval between the date of randomization and the earliest date of disease or death progression due to any cause in each treatment arm. Measure:Progression Free Survival (PFS) Timepoints:During the study ; Outcome name:Defined as the interval between the date of randomization and death due to any cause in each treatment arm. Measure:Overall Survival (OS) Timepoints:During the study ; Outcome name:Defined as CR + PR according to RECIST for each treatment arm Measure:Objective response rate (ORR) Timepoints:During treatment ; Outcome name:Recording of adverse events during the study Measure:Incidence, severity and causality of adverse events (EA), serious adverse events (EASs) and other safety parameters Timepoints:During the study | — |
Countries
Argentina, Brazil, Peru
Contacts
Public ContactHenery Leonidas Gomez
GRUPO ACADEMICO GECO
Outcome results
None listed