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

Sponsor GmbH10 sites in 1 country12 target enrollmentOctober 2010

ConditionsMetastatic Breast Cancer HER2 Positive First or Second Line Therapy Failure or Contraindication of Trastuzumab Therapy

InterventionsLapatinib and Capecitabine and Vinorelbine

DrugsLapatinib and Capecitabine and Vinorelbine

Overview

Phase: Phase 1
Intervention: Lapatinib and Capecitabine and Vinorelbine
Conditions: Metastatic Breast Cancer
Sponsor: Sponsor GmbH
Enrollment: 12
Locations: 10
Primary Endpoint: Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

July 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Sponsor GmbH

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

Capecitabine, Lapatinib, Vinorelbine

Intervention: Lapatinib and Capecitabine and Vinorelbine

Outcomes

Primary Outcomes

Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine

Time Frame: 4 months

Phase I: Identification of Dosis limiting toxicities and maximal tolerable dose for Combinational therapy (Time Frame: within the first 21 days under medication)