Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sponsor GmbH
With
iOMEDICO AG
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis Klinische Studien
GlaxoSmithKline
The combination of lapatinib with capecitabine ist a standard therapy für Her2 positive metastatic breast cancer. This study combines this therapy with the additional antimitotic mode of function by vinorelbine.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent
Able to comply with the protocol
ECOG performance status 0-1
Adequate contraception
Confirmed Her2/neu-positive, adenocarcinoma of the breast
At least one measurable lesion according to RECIST 1.1 criteria
First or second chemotherapy after diagnosis of metastasis
Lapatinib treatment indicated (adjuvant trastuzumab treatment \<12 months ago or progressive disease with trastuzumab treatment)
No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%
Adequate hepatic and renal function value
Adequate hematologic function values
You may not be if
Pregnant or lactating women
Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
Asymptomatic with regards to tumor illness
Previous treatment with lapatinib, capecitabine or vinorelbine
Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
History of vascular or cardiovascular disease within the past 6 months
All illnesses that result in malabsorption of oral medication or inability to take oral medication
Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
Concurrent treatment with allopurinol
Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ); patient can be included in the study if no recurrent disease has been observed for at least 5 years
Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
Clareo Health | Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer
