Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sponsor GmbH
• Collaborators: Arbeitsgemeinschaft fur Internistische Onkologie; Arbeitskreis Klinische Studien; GlaxoSmithKline; iOMEDICO AG
• Treatments: Capecitabine; Lapatinib; Vinblastine; Vinorelbine

Criteria

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