Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab
Key
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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