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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT01160094

Collaborator

(none)

288

Enrollment

Locations

40.9

Duration (Months)

26.2

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Treatment

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

288 participants

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 (TYCO)

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Patients ErbB2+ metastatic breast cancer patients	Drug: Treatment patients treated with Lapatinib-Capecitabine after Trastuzumab Progression

Arm

Intervention/Treatment

Patients

ErbB2+ metastatic breast cancer patients

Drug: Treatment

patients treated with Lapatinib-Capecitabine after Trastuzumab Progression

Outcome Measures

Primary Outcome Measures

Time to disease progression [One year]
the time from the date of start of Lapatinib capecitabine treatment until date of documented disease progression by the treating physician

Secondary Outcome Measures

Overall Response Rate [One year]
the percentage of patients showing complete response (CR) and partial response (PR) to the given treatment.
Overall survival [measured at the end of follow-up]
the time from the start of lapatinib capecitabine treatment until death due to any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novartis Investigative Site	Bogota	Colombia
2	Novartis Investigative Site	Bogotá	Colombia
3	Novartis Investigative Site	Bucaramanga	Colombia
4	Novartis Investigative Site	Medellin	Colombia
5	Novartis Investigative Site	Pasto	Colombia
6	Novartis Investigative Site	Pereira	Colombia
7	Novartis Investigative Site	Dammam	Saudi Arabia	Dammam 31444
8	Novartis Investigative Site	Jeddah	Saudi Arabia	21499
9	Novartis Investigative Site	Jeddah	Saudi Arabia	jEDDAH 21423
10	Novartis Investigative Site	Jeddah	Saudi Arabia
11	Novartis Investigative Site	Riyadh	Saudi Arabia