Role of Early Versus Late Switch to Lapatinib-Capecitabine

NCT01357863 | Terminated

• 1 other identifier: 113960
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 13

Brief Summary

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).

Conditions

Cancer

Keywords

Lapatinib; Observational Study; Trastuzumab; Brazil; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time to disease progression (TTP)

  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

  One year

Secondary Outcomes (4)

• Overall response rate (ORR) determined by treating physician

  One year

• One year overall survival (OS)

  One year

• Serious adverse events (SAEs)

  One year

• Clinical Global Impression (CGI)

  One year

Study Arms (2)

Patients on second line treatment

Patients treated with Lapatinib-capecitabine immediately after first Trastuzumab-containing regimen progression

Drug: Treatment

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

Interventions

Treatment DRUG

Patients treated with Lapatinib-capecitabine after Trastuzumab progression

Patients on second line treatment; Patients on third or more lines treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Vitória, Espírto Santo, 29055-270, Brazil

Location

GSK Investigational Site

Salvador, Estado de Bahia, 40110150, Brazil

Location

GSK Investigational Site

Salvador, Estado de Bahia, 41810-570, Brazil

Location

GSK Investigational Site

Salvador, Estado de Bahia, 41825-010, Brazil

Location

GSK Investigational Site

Goiânia, Goiás, 74140-050, Brazil

Location

GSK Investigational Site

Goiânia, Goiás, 74605-070, Brazil

Location

GSK Investigational Site

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90430-090, Brazil

Location

GSK Investigational Site

Florianópolis, Santa Catarina, 88034-000, Brazil

Location

GSK Investigational Site

São José dos Campos, São Paulo, Brazil

Location

GSK Investigational Site

Belo Horizonte, Brazil

Location

GSK Investigational Site

Rio de Janeiro, 22793-080, Brazil

Location

GSK Investigational Site

São Paulo, 01239-040, Brazil

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: July 15, 2010
• Primary Completion: December 13, 2010
• Study Completion: December 13, 2010
• Last Updated: September 14, 2018

Record last verified: 2018-05

Locations

BR (13)