Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248703
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2005-11-03
Brief Title:
Secondary Adjuvant Treatment for Patients With Isolated Tumor Cells in Bone Marrow
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Secondary Adjuvant Rescue Treatment With Docetaxel Taxotere and Detection of Isolated Tumor Cells in Bone Marrow as a Surrogate Marker for Effect in Node Positive and High Risk Node Negative Breast Cancer After Standard Adjuvant Epirubicin-containing Treatment
Status:
COMPLETED
Status Verified Date:
2022-04
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:
The purpose of this study is to identify patients with persisting tumor cells after standard epirubicin-containing treatment to test a non-cross resistant chemotherapy regimen docetaxel for these patients and to explore the analysis of disseminated tumor cells in bone marrow as a surrogate marker for clinical outcome
Detailed Description:
The presence of disseminating or isolated tumor cells DTCITC in bone marrow BM after completion of adjuvant chemotherapy for breast cancer is associated with poor prognosis Methods for detection of DTC have potential as a tool for monitoring occult residual disease during follow up Also there exists potent chemotherapy proven to be effective when anthracycline-based chemotherapy fails fex docetaxel Consequently a study has been started to test DTC detection as a surrogate marker for clinical outcome in localized breast cancer patients selected by the presence of DTC in BM after standard adjuvant chemotherapy receiving secondary treatment with docetaxel In brief patients having received anthracycline-containing chemotherapy for localized breast cancer are candidates After informed consent and no radiologic signs of distant metastasis the first BM aspiration is performed at the end of radiotherapy or 8-12 weeks after the last chemotherapy cycle The next BM aspiration is performed 6 months later At that time point the BMs are analyzed for the presence of DTC If DTC are present in the 6 months BM test the first BM sample is for exploratory research purposes 6 cycles of docetaxel are administered 3qw followed by a third and forth BM analysis 1 month and 13 months after the end of chemotherapy The patients receiving docetaxel with eradication of the DTC will be clinically compared to those with persistence of DTC after docetaxel treatment
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 |
|---|---|---|---|
| S-03-01434 | None | None | None |
| S-03032 | None | None | None |