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

NCT01160094 | Completed

• 1 other identifier: 113780
• Study Type: observational
• Target: 288
• Locations: 2 countries
• Sites: 10

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 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

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

Outcome Measures

Primary Outcomes (1)

• Time to disease progression

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

  One year

Secondary Outcomes (2)

• Overall Response Rate

  One year

• Overall survival

  measured at the end of follow-up

Study Arms (1)

Patients

ErbB2+ metastatic breast cancer patients

Drug: Treatment

Interventions

Treatment DRUG

patients treated with Lapatinib-Capecitabine after Trastuzumab Progression

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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. Patients from private and public settings.

* 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.

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

Sponsors & Collaborators

• Novartis: lead

Study Sites (10)

Novartis Investigative Site

Bogotá, Colombia

Location

Novartis Investigative Site

Bucaramanga, Colombia

Location

Novartis Investigative Site

Medellín, Colombia

Location

Novartis Investigative Site

Pasto, Colombia

Location

Novartis Investigative Site

Pereira, Colombia

Location

Novartis Investigative Site

Dammam, Dammam 31444, Saudi Arabia

Location

Novartis Investigative Site

Jeddah, 21499, Saudi Arabia

Location

Novartis Investigative Site

Jeddah, jEDDAH 21423, Saudi Arabia

Location

Novartis Investigative Site

Jeddah, Saudi Arabia

Location

Novartis Investigative Site

Riyadh, Saudi Arabia

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

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 12, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 28, 2016

Record last verified: 2016-03

Locations

SA (5); CO (5)