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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival related to presence or absence of disseminated tumor cells
At approximately 8 years maximum FU
No
Bjørn Naume, MD, PhD
Principal Investigator
Oslo University Hospital
Norway: Norwegian Medicines Agency
NBCG9
NCT00248703
October 2003
November 2013
Name | Location |
---|