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

Completed

Conditions: Breast cancer
invasive mammary carcinoma
10006291

Registration Number: NL-OMON49077

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 87

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. 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;
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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is a CTC detection rate through the DLA method of 15% in<br /><br>the 1-3 PLN group and 30% in the >=4 PLN group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The concordance of the CTC detection rate in DLA product vs the CTC detection<br /><br>rate in 7.5mL and in 30mL blood samples per patient<br /><br>- The detection rate of CTCs compared to the detection rate of circulating<br /><br>tumor (ct)DNA per patient.<br /><br>- To assess the incidence of lymphedema following DLA using the Lymph-ICF<br /><br>questionnaire and arm circumference measure.</p><br>