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

Not Applicable

Completed

Conditions: <p>ER+, HER2 negative breast cancer, positive lymph nodes at diagnosis</p>
Breast cancer
10006232

Registration Number: NL-OMON23853

Lead Sponsor: KWF

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. 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

Study & Design

Study Type: Observational non 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 the 1-3 PLN group and 30% in the =4 PLN group.</p><br>

Secondary Outcome Measures

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