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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

Lapatinib and Capecitabine and Vinorelbine

Ulrike Soeling, MD

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.

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.

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

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

Measurement with CT or MRI after three and six cycles and every three months, as long no tumor progression is detected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer	NCT01238029	Metastatic Brea... HER2 Positive First or Second... Failure or Cont...	Lapatinib and C...	18 Years -	Sponsor GmbH
Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer	NCT01238029	Metastatic Brea... HER2 Positive First or Second... Failure or Cont...	Lapatinib and C...	18 Years -	Sponsor GmbH

Spots Global Cancer Trial Database for lapatinib and capecitabine and vinorelbine