Role of Early Versus Late Switch to Lapatinib-Capecitabine ((TYCO1))

This study has been terminated.
(This study was terminated because the National Ethics Committee has not approved the protocol.)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01357863
First received: May 19, 2011
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention
Cancer
Breast Cancer
Drug: Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to disease progression (TTP) [ Time Frame: One year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Overall response rate (ORR) determined by treating physician [ Time Frame: One year ] [ Designated as safety issue: No ]
    Percentage of patients showing complete response (CR) and partial response (PR) to the given treatment

  • One year overall survival (OS) [ Time Frame: One year ] [ Designated as safety issue: No ]
    Time from the start of lapatinib-capecitabine treatment until death due to any cause (measured at the end of follow-up)

  • Serious adverse events (SAEs) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Describe lapatinib-related spontaneous reported serious adverse events

  • Clinical Global Impression (CGI) [ Time Frame: One year ] [ Designated as safety issue: No ]
    CGI assessment by the treating physician in the last visit (visit 4 or discontinuation visit)


Enrollment: 3
Study Start Date: July 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients on second line treatment
Patients treated with Lapatinib-capecitabine immediately after first Trastuzumab-containing regimen progression
Drug: Treatment
Patients treated with Lapatinib-capecitabine after Trastuzumab progression
Patients on third or more lines treatment
Patients treated with Lapatinib-capecitabine after 2 or more lines of treatment after first Trastuzumab-containing regimen progression
Drug: Treatment
Patients treated with Lapatinib-capecitabine after Trastuzumab progression

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Centers from private and public settings, which have incorporated Lapatinib treatment in their routine clinical practice, will be included in this study. Data on the country, type of center, and facility name will be collected on the case report form for use in the data analysis.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357863

Locations
Brazil
GSK Investigational Site
Salvador, Bahía, Brazil, 41825-010
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01357863     History of Changes
Other Study ID Numbers: 113960
Study First Received: May 19, 2011
Last Updated: January 12, 2012
Health Authority: Brazil: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Lapatinib
Observational Study
Trastuzumab
Brazil
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Capecitabine
Lapatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014