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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01238029

Acronym

CELAVIE

Enrollment

Registered

2010-11-10

Start date

2010-10-31

Completion date

2014-07-31

Last updated

2014-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Dose finding study, Combination

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.

Interventions

DRUGLapatinib and Capecitabine and Vinorelbine

Dose finding Study Lapatinib: 1000-1250 oral, once daily, days 1-21 Capecitabine: 1000 mg/sqm oral, bid, days 1-14 Vinorelbine 10-22,5 mg/sqm, i.v. Day 1 + 8

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine	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)

Secondary

Measure	Time frame	Description
Overall response Rate	12 months	Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Progression free survival	12 months	Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Time to treatment failure (TTF)	12 months	Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.
Overall survival (OS)	12 months	Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026