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

Sponsor

Status and phase

Terminated

Phase 1

Conditions

First or Second Line Therapy

HER2 Positive

Metastatic Breast Cancer

Failure or Contraindication of Trastuzumab Therapy

Treatments

Drug: Lapatinib and Capecitabine and Vinorelbine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01238029

0907-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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