NL-OMON23853
Completed
未知
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
KWF0 sites87 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- KWF
- Enrollment
- 87
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female 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\. Provided 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 109/L; Patients not on anticoagulant therapy which affects PT or APTT if: o PT \> 1\.5 x ULN or PT\-INR \> 1\.5 x ULN o APTT \> 1\.5 x ULN Patients who take anticoagulant therapy which affects PT or APTT if: o PT or APTT \> 1\.5 x the upper limit of the desired therapeutic window o Total bilirubin \> 2\.5 x ULN 6\. BMI \= 35 kg/m2
Outcomes
Primary Outcomes
Not specified
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