Overview

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