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

Phase 1

Terminated

• Conditions: Failure or Contraindication of Trastuzumab Therapy; First or Second Line Therapy; Metastatic Breast Cancer; HER2 Positive
• Interventions: Drug: Lapatinib and Capecitabine and Vinorelbine

• Registration Number: NCT01238029
• Lead Sponsor: Sponsor GmbH

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine, Lapatinib, Vinorelbine	Lapatinib and Capecitabine and Vinorelbine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

Onkologische Schwerpunktpraxis Leer Emden; 🇩🇪 Leer, Niedersachsen, Germany

Praxisgemeinschaft Dres. Siehl und Söling; 🇩🇪 Kassel, Hessen, Germany

Onkologische Schwerpunktpraxis; 🇩🇪 Heidelberg, Germany

Schwerpunktpraxis Hämatologie / Onkologie; 🇩🇪 Stade, Niedersachsen, Germany

Onkodok (Dr. Rösel und Dr. Depenbusch); 🇩🇪 Guetersloh, Nordrhein-Westfalen, Germany

Hämatologisch-onkologische Gemeinschaftspraxis; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Praxis für Hämatologie und Onkologie; 🇩🇪 Mulheim an der Ruhr, Nordrhein-Westfalen, Germany

Praxis für Onkologie u. Hämatologie; 🇩🇪 Neuss, Nordrhein-Westfalen, Germany

Onkologische Gemeinschaftspraxis Dörfel/Göhler; 🇩🇪 Dresden, Saxony, Germany

Onkologie Ravensburg; 🇩🇪 Ravensburg, Baden-Württemberg, Germany