Status:
COMPLETED
Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)
Lead Sponsor:
Novartis
Conditions:
Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
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 tras...
Detailed Description
Lapatinib in combination with capecitabine is a standard of care treatment for ErbB2+ metastatic breast cancer (MBC) patients who have progressed after anthracyclines, taxanes and trastuzumab treatmen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT01160094
Start Date
February 1 2010
End Date
July 1 2013
Last Update
March 28 2016
Active Locations (10)
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1
Novartis Investigative Site
Bogotá, Colombia
2
Novartis Investigative Site
Bucaramanga, Colombia
3
Novartis Investigative Site
Medellín, Colombia
4
Novartis Investigative Site
Pasto, Colombia