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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23853

Enrollment

Registered

2020-04-21

Start date

2020-11-03

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ER+, HER2 negative breast cancer, positive lymph nodes at diagnosis Breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactNoortje Verschoor

Erasmus MC

n.verschoor@erasmusmc.nl0107044375

Outcome results