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Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)

18 Years
Open (Enrolling)

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Trial Information

Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)

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 treatment. Results from the lapatinib pivotal trial showed that the addition
of lapatinib to capecitabine increased median time to progression (TTP) even among heavily
pre-treated patients (median of 4 prior lines of therapy). A recent ad hoc subset analysis
of this trial suggested that earlier administration of lapatinib-capecitabine in MBC
patients who progress after trastuzumab may produce better clinical outcomes. The TYCO study
was designed to evaluate if early switch to lapatinib-capecitabine in patients with ErbB2+
MBC who have progressed on trastuzumab-containing regimen improves TTP in comparison with a
later start (after several lines of therapy). Secondary objectives include Overall Response
Rate (ORR), 1 year Overall Survival (OS), and description of reported serious adverse
events. This is an international, multicenter, prospective, observational
(non-interventional) study in 269 ErbB2+MBC patients whose disease has progressed after
treatment with trastuzumab. Two cohorts will be compared; Group 1: patients receiving
lapatinib-capecitabine immediately after first trastuzumab progression, and Group 2:
patients receiving lapatinib-capecitabine after two or more lines of treatment after first
trastuzumab progression. Eligibility criteria include females aged 18 or more with confirmed
ErbB2+ MBC who have progressed after a previous trastuzumab-containing regimen, eligible to
start standard therapy with lapatinib-capecitabine at approved conventional doses, as per
local label approval. The study duration is of 12 months with data collection at baseline
and approximately every 3 months thereafter. Patient evaluations will be conducted per
standard patient care in each center and TTP will be determined by the treating physician
(clinically or radiologically). Enrollment started in February 2010 and completion of
accrual is estimated for December 2011.

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

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Time to disease progression

Outcome Description:

the time from the date of start of Lapatinib capecitabine treatment until date of documented disease progression by the treating physician

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Saudi Arabia: Ethics Review Board

Study ID:




Start Date:

February 2010

Completion Date:

December 2013

Related Keywords:

  • Cancer
  • Breast Cancer
  • Trastuzumab
  • Metastatic Breast Cancer
  • Observational Study
  • Lapatinib