Role of Early Versus Late Switch to Lapatinib-Capecitabine

Cancer Clinical Trial

— (TYCO1)  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01357863
• Other study ID #: 113960
• Status: Terminated
• Start date: July 15, 2010
• Est. completion date: December 13, 2010

Study information

• Verified date: May 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 13, 2010
• Est. primary completion date: December 13, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Treatment
Patients treated with Lapatinib-capecitabine after Trastuzumab progression

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Belo Horizonte
Brazil	GSK Investigational Site	Florianopolis	Santa Catarina
Brazil	GSK Investigational Site	Goiania	Goiás
Brazil	GSK Investigational Site	Goiania	Goiás
Brazil	GSK Investigational Site	Natal	Rio Grande Du Norte
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Rio de Janeiro
Brazil	GSK Investigational Site	Salvador	Bahía
Brazil	GSK Investigational Site	Salvador	Bahía
Brazil	GSK Investigational Site	Salvador	Bahía
Brazil	GSK Investigational Site	São José dos Campos	São Paulo
Brazil	GSK Investigational Site	São Paulo
Brazil	GSK Investigational Site	Vitoria	Espírto Santo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease progression (TTP)	Time from the date of start of Lapatinib-capecitabine treatment until date of documented disease progression by the treating physician, determined by clinical and/or radiological assessment	One year
Secondary	Overall response rate (ORR) determined by treating physician	Percentage of patients showing complete response (CR) and partial response (PR) to the given treatment	One year
Secondary	One year overall survival (OS)	Time from the start of lapatinib-capecitabine treatment until death due to any cause (measured at the end of follow-up)	One year
Secondary	Serious adverse events (SAEs)	Describe lapatinib-related spontaneous reported serious adverse events	One year
Secondary	Clinical Global Impression (CGI)	CGI assessment by the treating physician in the last visit (visit 4 or discontinuation visit)	One year