Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496366
Status:
TERMINATED
Last Update Posted:
2017-03-21
First Post:
2007-07-03
Brief Title:
Capecitabine Xeloda and Lapatinib Tykerb as First-line Therapy in HER2Neu-positive Breast Cancer
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Phase II Trial of Capecitabine Xeloda and Lapatinib Tykerb as First-line Therapy in Patients With HER2Neu-Overexpressing Advanced or Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects with advanced or metastatic spread to other parts of the body breast cancer that is HER2neu-positive will take part in this study This type of breast cancer has a high amount of a protein called HER2 HER2 is part of a family of receptors found on both cancer and normal cells This family of receptors is important for cell growth and is found in many tumor types The purpose of this research study is to compare an approved treatment for breast cancer capecitabine also called Xeloda to the combination of capecitabine plus an experimental drug lapatinib also known as Tykerb for treatment of advanced or metastatic breast cancer that is HER2neu-positiveCapecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth Lapatinib Tykerb is considered investigational which means the drug has not been approved by the US Food and Drug Administration FDA for sale as a prescription or over-the-counter medication Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells However this theory has not been proven The addition of the study drug lapatinib to capecitabine may help stop cancer cells as well as or better than capecitabine alone Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancerSubjects will receive capecitabine and lapatinib A treatment period will be 21 days long This period is known as a cycle All medications will be given by mouth Subjects will take capecitabine for 2 weeks straight Day 1-14 followed by a 1 week without capecitabine Day 15-21 Doses of lapatinib will be taken daily continuously for 21 days Day 1-Day 21 which means that subjects will still take lapatinib on the week that they do not take capecitabine Day 15-21 Subjects will continue to receive these medications unless they experience severe serious andor excessive side effects the cancer becomes worse the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatmentTests and procedures such as physical exam blood tests CT or MRI ECG ECHO andor MUGA tests will be conducted at one or more of the following time points before the study starts before each cycle every 6 and 12 weeks and after the last dose of capecitabinelapatinib treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0220070103 | OTHER | IRB | None |
| NJ 1106 | None | None | None |