Secondary Adjuvant Treatment for Patients With Isolated Tumor Cells in Bone Marrow
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Disease free survival related to presence or absence of disseminated tumor cells [ Time Frame: At approximately 8 years maximum FU ] [ Designated as safety issue: No ]
- Predictive value of primary tumor markers on effects of docetaxel [ Time Frame: At approximately 8 years maximum FU ] [ Designated as safety issue: No ]
- Explore markers on tumor cells in bone marrow that can predict the effect of docetaxel [ Time Frame: At approximately of 8 years maximum FU ] [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Patients with presence of disseminated tumor cells in bone marrow after (no-taxane) epirubicin-containing adjuvant treatment receive 6 cycles of docetaxel (100 mg/m2) 3 qw.
Docetaxel 100 mg/m2 3 qw x 6
Other Name: Taxotere
The presence of disseminating (or isolated) tumor cells (DTC/ITC) 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 (f.ex. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248703
|Oslo, Norway, 0027|
|Principal Investigator:||Bjørn Naume, MD, PhD||Oslo University Hospital|