Safety Study in Subjects With Metastatic Breast Cancer Who Progressed After Taxanes Treatment. GLICO-0801
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-059-09
- Lead Sponsor
- Grupo Latinoamericano de Investigaciones Clinicas en Oncologica (GLICO),
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 0
• 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 • Prior treatment with endocrine therapy is allowed if the therapy has been discontinued before randomization, and all adverse events related to treatment are • Previous treatments with radiotherapy for palliative management of metastatic disease, to a limited area (eg, palliative treatment for painful disease) at a different site than the measurable disease and the disease evaluated, it is allowed, however, the subjects must have Treatment completed at least 4 weeks after the last dose of radiotherapy prior to starting the study drugs, and must have recovered from treatment-related toxicities before day 1.11. The life expectancy is at least 6 months.
• ECOGPSO-2.
• Patients must have normal organs and marrow function measured within 14 days prior to randomization.
• Brain tomography / MRI 4 weeks before randomization.
• Women with potential fertility (WOCBP) must have a negative urine or serum pregnancy test (minimum sensitivity 25 lU / L or equivalent units of HCG) within 7 days prior to registration.
• Patients must have at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST, Therasse, 2000). Medial lesions may be in the field of prior adjuvant radiation. However, there must be at least a 4-week period between the last radiation treatment and baseline Tomography documented the disease status. The documented progression of the irradiated lesion is also required so that the lesion can be considered measurable.
• Subjects must have a fraction of cardiac ejection in the normal institutional range measured by ECO (echocardiogram) or alternatively by MUGA Tomography (Multigramic Acquisition). The cardiac ejection fraction> 50% and in the normal institutional range demonstrated by echocardiogram or alternatively by MUGA Tomography betwe
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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<br>Measure:Clinical Benefit Rate (CBR)<br>Timepoints:24 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>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.<br>Measure:Progression Free Survival (PFS)<br>Timepoints:During the study<br>;<br>Outcome name:Defined as the interval between the date of randomization and death due to any cause in each treatment arm.<br>Measure:Overall Survival (OS)<br>Timepoints:During the study<br>;<br>Outcome name:Defined as CR + PR according to RECIST for each treatment arm<br>Measure:Objective response rate (ORR)<br>Timepoints:During treatment<br>;<br>Outcome name:Recording of adverse events during the study<br>Measure:Incidence, severity and causality of adverse events (EA), serious adverse events (EASs) and other safety parameters<br>Timepoints:During the study<br>