Last updated: 11/03/2018 15:37:40
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Role of early versus late switch to Lapatinib-Capecitabine (TYCO1)TYCO
GSK study ID
113780
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
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 (TYCO)
Trial description: It will be conducted as an international multicenter prospective observational cohort study 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
Timeframe: One year
Secondary outcomes:
Overall Response Rate
Timeframe: One year
Overall survival
Timeframe: measured at the end of follow-up
Interventions:
Drug: Treatment
Enrollment:
276
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Cancer, Neoplasms
Product
lapatinib
Collaborators
Not applicable
Study date(s)
February 2010 to August 2015
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
none
- 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, OR receiving standard treatment with
- Lapatinib-capecitabine at conventional doses, for no longer than 10 weeks from the start of the treatment to the date of inclusion in the study;
- Signed consent to participate and release information for this study.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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