Clinical trial NCT01357863: Role of Early Versus Late Switch to Lapatinib-Capecitabine
Official title: Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO1) - Brazil
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: Lapatinib
Observational Study
Trastuzumab
Brazil
Metastatic Breast Cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Centers from private and public settings, which have incorporated Lapatinib treatment in their routine clinical practice, will be included in this study. Data on the country, type of center, and facility name will be collected on the case report form for use in the data analysis.

Brief summary: 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: 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.

Eligibility criteria: * Women with ErbB2+ MBC (ErbB2 expression confirmed by immunohistochemistry or FISH/CISH, either in the primary tumor or in the metastasis, according to the institution's common practice);
* Older than 18 years old;
* Have received prior treatment with trastuzumab-containing regimen for ErbB2+ breast cancer;
* Progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment;
* Eligible to start standard treatment with Lapatinib-capecitabine at conventional doses, in the community setting;
* Signed consent to participate and release information for this study.

Primary outcomes:
measure: Time to disease progression (TTP)
timeFrame: One year
Secondary outcomes:
measure: Overall response rate (ORR) determined by treating physician
timeFrame: One year
measure: One year overall survival (OS)
timeFrame: One year
measure: Serious adverse events (SAEs)
timeFrame: One year
measure: Clinical Global Impression (CGI)
timeFrame: One year
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: GSK Investigational Site
state: Bahía
city: Salvador
country: Brazil
facility: GSK Investigational Site
state: Bahía
city: Salvador
country: Brazil
facility: GSK Investigational Site
state: Bahía
city: Vitoria
country: Brazil
facility: GSK Investigational Site
state: Espírto Santo
city: Goiania
country: Brazil
facility: GSK Investigational Site
state: Goiás
city: Goiania
country: Brazil
facility: GSK Investigational Site
state: Goiás
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Natal
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Du Norte
city: Florianopolis
country: Brazil
facility: GSK Investigational Site
state: Santa Catarina
city: São José dos Campos
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Belo Horizonte
country: Brazil
facility: GSK Investigational Site
city: Rio de Janeiro
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: