Role of Early Versus Late Switch to Lapatinib-Capecitabine

NCT ID: NCT01357863

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-15

Study Completion Date

2010-12-13

Brief Summary

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The study will be conducted as a multicenter prospective observational cohort study, trying to cover almost all Brazilian States, in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).

Detailed Description

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All cases of ErbB2 positive metastatic breast cancer, receiving approved standard treatment with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community setting can participate in this observational study, for a period of 12 months of observation since the start of the lapatinib-capecitabine treatment.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients on second line treatment

Patients treated with Lapatinib-capecitabine immediately after first Trastuzumab-containing regimen progression

Treatment

Intervention Type DRUG

Patients treated with Lapatinib-capecitabine after Trastuzumab progression

Patients on third or more lines treatment

Patients treated with Lapatinib-capecitabine after 2 or more lines of treatment after first Trastuzumab-containing regimen progression

Treatment

Intervention Type DRUG

Patients treated with Lapatinib-capecitabine after Trastuzumab progression

Interventions

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Treatment

Patients treated with Lapatinib-capecitabine after Trastuzumab progression

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed consent to participate and release information for this study.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Vitória, Espírto Santo, Brazil

Site Status

GSK Investigational Site

Salvador, Estado de Bahia, Brazil

Site Status

GSK Investigational Site

Salvador, Estado de Bahia, Brazil

Site Status

GSK Investigational Site

Salvador, Estado de Bahia, Brazil

Site Status

GSK Investigational Site

Goiânia, Goiás, Brazil

Site Status

GSK Investigational Site

Goiânia, Goiás, Brazil

Site Status

GSK Investigational Site

Natal, Rio Grande do Norte, Brazil

Site Status

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

GSK Investigational Site

Florianópolis, Santa Catarina, Brazil

Site Status

GSK Investigational Site

São José dos Campos, São Paulo, Brazil

Site Status

GSK Investigational Site

Belo Horizonte, , Brazil

Site Status

GSK Investigational Site

Rio de Janeiro, , Brazil

Site Status

GSK Investigational Site

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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113960

Identifier Type: -

Identifier Source: org_study_id

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