Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-05 @ 4:33 AM
Study NCT ID:
NCT01873833
Status:
TERMINATED
Last Update Posted:
2023-10-05
First Post:
2013-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Phase II Trial of Metronomic Capecitabine and Cyclophosphamide With Lapatinib and Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well capecitabine, cyclophosphamide, lapatinib ditosylate, and trastuzumab work in treating patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving capecitabine and cyclophosphamide daily may kill more tumor cells. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving capecitabine, cyclophosphamide, lapatinib ditosylate, and trastuzumab together may be an effective treatment for breast cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. To estimate the progression free survival (PFS).
SECONDARY OBJECTIVES:
I. To evaluate the overall response rate (ORR).
II. To evaluate the clinical benefit rate (CBR; complete response, partial response, and stable disease for \>= 24 weeks).
III. To estimate the overall survival (OS).
IV. To assess the safety and tolerability.
OUTLINE:
Patients receive capecitabine orally (PO) once daily (QD), cyclophosphamide PO QD, and lapatinib ditosylate PO QD on days 1-21 and trastuzumab intravenously (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
I. To estimate the progression free survival (PFS).
SECONDARY OBJECTIVES:
I. To evaluate the overall response rate (ORR).
II. To evaluate the clinical benefit rate (CBR; complete response, partial response, and stable disease for \>= 24 weeks).
III. To estimate the overall survival (OS).
IV. To assess the safety and tolerability.
OUTLINE:
Patients receive capecitabine orally (PO) once daily (QD), cyclophosphamide PO QD, and lapatinib ditosylate PO QD on days 1-21 and trastuzumab intravenously (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01086 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA014089 | NIH | None | https://reporter.nih.gov/quic… | View |