Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-06 @ 11:12 PM
Study NCT ID:
NCT01985893
Status:
WITHDRAWN
Last Update Posted:
2016-01-14
First Post:
2013-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Lapatinib Plus Trastuzumab or Lapatinib Plus Capecitabine in Metastatic Breast Cancer
Sponsor:
Berufsverband Niedergelassener Gynäkologischer Onkologen in Deutschland e.V.
Organization:
Study Overview
Official Title:
Randomised, Open-label Phase II Study to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab or Lapatinib Plus Capecitabine in Trastuzumab-resistant HER2-overexpressing Metastatic Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to missing patient recruitment, the financial support was stopped.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THOR
Brief Summary:
The purpose of this study is to estimate the clinical benefit of lapatinib plus trastuzumab compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free survival, tumour response and overall survival.
Detailed Description:
This is an open-label, randomized, explorative phase II trial of lapatinib plus trastuzumab or lapatinib plus capecitabine in patients with HER2 overexpressing metastatic breast cancer. The trial is designed to obtain some evidence wether chemotherapy-free combined HER2-directed therapy with lapatinib and trastuzumab provides a similar efficacy as the established combination of lapatinib with capecitabine and a more favourable toxicity profile. This study will also assess the relationship between the anticipated anti-tumour activity of the treatment regimens and biological characteristics of subjects' tumour at baseline.
The purpose of this study is to estimate the clinical benefit of lapatinib plus trastuzumab compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free survival, tumour response and overall survival.
The purpose of this study ist further
* to characterize the safety and tolerability of lapatinib plus trastuzumab in this population.
* to identify predictors of sensitivity to lapatinib and trastuzumab therapy. and
* to compare the differences in health-related quality of life (HRQL) and pain symptoms for patients by treatment assignment.
The purpose of this study is to estimate the clinical benefit of lapatinib plus trastuzumab compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free survival, tumour response and overall survival.
The purpose of this study ist further
* to characterize the safety and tolerability of lapatinib plus trastuzumab in this population.
* to identify predictors of sensitivity to lapatinib and trastuzumab therapy. and
* to compare the differences in health-related quality of life (HRQL) and pain symptoms for patients by treatment assignment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: