Know Cancer

or
forgot password

Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO1) - Brazil


N/A
18 Years
N/A
Not Enrolling
Female
Cancer, Breast Cancer

Thank you

Trial Information

Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO1) - Brazil


All cases of ErbB2 positive metastatic breast cancer, receiving approved standard treatment
with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community
setting can participate in this observational study, for a period of 12 months of
observation since the start of the lapatinib-capecitabine treatment.

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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Time to disease progression (TTP)

Outcome Description:

Time from the date of start of Lapatinib-capecitabine treatment until date of documented disease progression by the treating physician, determined by clinical and/or radiological assessment

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Brazil: Institutional Review Board

Study ID:

113960

NCT ID:

NCT01357863

Start Date:

July 2010

Completion Date:

February 2011

Related Keywords:

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

Name

Location