Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Vinorelbine

Lapatinib

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients will receive 1250mg lapatinib once a day for 24 weeks.

Patients will receive vinorelbine 25mg/sqm IV Day 1 and Day 8, every 3 week for 24 weeks.

Patients will receive 1250mg lapatinib once a day and vinorelbine 25mg/sqm IV Day 1and Day 8, every 3 week for 24 weeks.

lapatinib and Vinorelbine

GSK Clinical Trials

This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted therapy in the metastatic and relaps setting.

This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted therapy in the metastatic and relaps setting.

Patients will receive 1250mg lapatinib once a day and vinorelbine 25mg/sqm IV Day 1and Day 8, every 3 week for 24 weeks. The study treatment will continue until patients experience disease progression or unacceptable toxicity. The primary objective of the study is the objective response rate (ORR, defined as CR + PR) and toxicity. Secondary objectives include DFS, duration of response.

Lapatinib in Combination With Vinorelbine

A Multicenter, Open-Label, Phase II Study of Lapatinib in Combination With Vinorelbine in Subjects With ErbB2 Amplified Recurrent and Metastatic Breast Cancer

Par. with CB are defined as those with complete response (CR), partial response (PR), or stable disease (SD) for \>=12 or 24 weeks. Per Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1, CR is defined as the disappearance of all target lesions, PR is defined as a \>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as a reference the smallest sum LD since the treatment started.

Per RECIST, Version 1.1, Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Duration of response was measured in participants who experienced either a complete response or a partial response. Per RECIST, Version 1.1, complete response is defined as the disappearance of all target lesions, and partial response is defined as a \>=30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter.

GlaxoSmithKline

Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m\^2) intravenously on Day 1 and Day 8, and every 3 weeks.

Lapatinib 1250 mg and Vinorelbine 20 mg/m^2

Age Continuous

Sex: Female, Male

Caucasian

Race/Ethnicity, Customized

GSK Response Center

Week 12, CR

Week 12, PR

Week 12, SD

Week 24, CR

Week 24, PR

Week 24, SD

All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.

Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24

Progression-free Survival

All participants randomized to receive at least one dose of study drug. Only those participants with a complete or partial response were evaluated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Lapatinib in Combination With Vinorelbine	NCT01128543	Cancer	lapatinib and V...	18 Years -	GlaxoSmithKline
Lapatinib in Combination With Vinorelbine	NCT01128543	Cancer	lapatinib and V...	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for lapatinib and vinorelbine