Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508274
Status:
TERMINATED
Last Update Posted:
2021-09-21
First Post:
2007-07-26
Brief Title:
Lapatinib Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open-Label Multicenter Study Administering Lapatinib and Capecitabine Xeloda in Women With Advanced or Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary analysis was completed in 2015 and data collection post 1-Jul-2019 was not reportable due to local regulations in China
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Local study in China and Hong Kong to evaluate safety and efficacy in lapatinib capecitabine in women with Human epidermal growth factor receptor 2 HER2 positive advanced or metastatic breast cancer
Detailed Description:
The Primary objective of the study was to evaluate the overall clinical benefit response CBR rate
This was a single arm open-label multi-center study of lapatinib plus capecitabine in women from mainland China and Hong Kong who had advanced or metastatic breast cancer that progressed on prior chemotherapies with or without trastuzumab
Participants received study treatment until disease progression unacceptable toxicity or withdrawal for any other reasons
This was a single arm open-label multi-center study of lapatinib plus capecitabine in women from mainland China and Hong Kong who had advanced or metastatic breast cancer that progressed on prior chemotherapies with or without trastuzumab
Participants received study treatment until disease progression unacceptable toxicity or withdrawal for any other reasons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CLAP016A2304 | OTHER | Novartis | None |