(TYCO1): Role of Early Versus Late Switch to Lapatinib-Capecitabine

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Terminated

CT.gov ID

NCT01357863

Collaborator

(none)

Enrollment

Locations

Duration (Months)

0.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Treatment

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.

Study Design

Study Type:

Observational

Actual Enrollment :

3 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Jul 15, 2010

Actual Primary Completion Date :

Dec 13, 2010

Actual Study Completion Date :

Dec 13, 2010

Arms and Interventions

Arm	Intervention/Treatment
Patients on second line treatment Patients treated with Lapatinib-capecitabine immediately after first Trastuzumab-containing regimen progression	Drug: Treatment 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	Drug: Treatment Patients treated with Lapatinib-capecitabine after Trastuzumab progression

Arm

Intervention/Treatment

Patients on second line treatment

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

Drug: Treatment

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

Drug: Treatment

Patients treated with Lapatinib-capecitabine after Trastuzumab progression

Outcome Measures

Primary Outcome Measures

Time to disease progression (TTP) [One year]
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

Secondary Outcome Measures

Overall response rate (ORR) determined by treating physician [One year]
Percentage of patients showing complete response (CR) and partial response (PR) to the given treatment
One year overall survival (OS) [One year]
Time from the start of lapatinib-capecitabine treatment until death due to any cause (measured at the end of follow-up)
Serious adverse events (SAEs) [One year]
Describe lapatinib-related spontaneous reported serious adverse events
Clinical Global Impression (CGI) [One year]
CGI assessment by the treating physician in the last visit (visit 4 or discontinuation visit)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Salvador	Bahía	Brazil	40110150
2	GSK Investigational Site	Salvador	Bahía	Brazil	41810-570
3	GSK Investigational Site	Salvador	Bahía	Brazil	41825-010
4	GSK Investigational Site	Vitoria	Espírto Santo	Brazil	29055-270
5	GSK Investigational Site	Goiania	Goiás	Brazil	74140-050
6	GSK Investigational Site	Goiania	Goiás	Brazil	74605-070
7	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90430-090
8	GSK Investigational Site	Natal	Rio Grande Du Norte	Brazil	59075-740
9	GSK Investigational Site	Florianopolis	Santa Catarina	Brazil	88034-000
10	GSK Investigational Site	São José dos Campos	São Paulo	Brazil
11	GSK Investigational Site	Belo Horizonte		Brazil
12	GSK Investigational Site	Rio de Janeiro		Brazil	22793-080
13	GSK Investigational Site	São Paulo		Brazil	01239-040