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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49077

Enrollment

Registered

2020-07-08

Start date

2020-11-03

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Breast cancer invasive mammary carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 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

Exclusion criteria

Exclusion criteria: 1. Prior non-breast malignancies 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
- 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.	—

Countries

Netherlands

Outcome results