NL-OMON49077
Completed
Not Applicable
Development of a more sensitive method to predict breast cancer recurrence after 5-years of endocrine treatment making use of diagnostic leukapheresis to detect circulating tumor cells - Sibylla
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 87
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •2\. Age \>18 years
- •3\. Diagnosed with ER\+ Her2\-negative lymph node positive, primary breast cancer
- •4\. Received at least 4\.5 \- 5\.5 years of adjuvant ET for breast cancer
- •including those who are \<6 months after finishing endocrine therapy.
- •5\. No clinical signs of locoregional or distant recurrence.
- •6\. At least one adequate peripheral vein in both arms as access for
- •leukapheresis.
- •7\. Provide written informed consent
Exclusion Criteria
- •1\. Prior non\-breast malignancies \<5 years of inclusion, except for basal or
- •squamous cell carcinoma of the skin
- •2\. Pre\-existing lymphedema, quantified by specialist
- •3\. Known hypersensitivity to the used anticoagulant (ACD)
- •4\. Inadequate cardiac function or severe cardiovascular comorbidity (heart
- •failure NYHA class III/IV)
- •5\. Coagulation disorders as defined by one of the following:
- •NOTE: the use of all types of anticoagulant therapy is permitted
- •o Coagulation disorder in medical history
- •o Platelet count \< 40 x 10^9/L;
Outcomes
Primary Outcomes
Not specified
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