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
Discontinued
Discontinued
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:
Drug: Treatment
Enrollment:
3
Observational study model:
Cohort
Primary completion date:
Not applicable
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, Bahía, 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
Location
GSK Investigational Site
Natal, Rio Grande Du Norte, Brazil, 59075-740
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Goiania, Goiás, Brazil, 74140-050
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salvador, Bahía, Brazil, 40110150
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Florianopolis, Santa Catarina, Brazil, 88034-000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vitoria, Espírto Santo, Brazil, 29055-270
Status
Terminated/Withdrawn
Location
GSK Investigational Site
São José dos Campos, São Paulo, Brazil
Status
Study Complete
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
Discontinued
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
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