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Clinical Trials/NL-OMON49077
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

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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