Last updated: 11/03/2018 15:54:08
Role of early versus late switch to Lapatinib-Capecitabine(TYCO1)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Time to disease progression (TTP)
Timeframe: One year
Secondary outcomes:
Overall response rate (ORR) determined by treating physician
Timeframe: One year
One year overall survival (OS)
Timeframe: One year
Serious adverse events (SAEs)
Timeframe: One year
Clinical Global Impression (CGI)
Timeframe: One year
Interventions:
Enrollment:
3
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Cancer
Product
lapatinib
Collaborators
Not applicable
Study date(s)
July 2010 to December 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- 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;
Inclusion and exclusion criteria
Inclusion 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.
Trial location(s)
Location
GSK Investigational Site
Goiania, Goiás, Brazil, 74605-070
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 22793-080
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salvador, BahÃa, Brazil, 41810-570
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90430-090
Status
Terminated/Withdrawn
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 01239-040
Status
Study Complete
Showing 1 - 6 of 13 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
2010-13-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website