Metastatic breast cancer
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult women (>= 18 years of age) with proven diagnosis of adenocarcinoma of the breast with locoregional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent. 2. Documentation of histologically or cytologically confirmed diagnosis of estrogen receptor (ER) expression >10% and/or progesterone receptor (PR) expression >10% breast cancer based on local laboratory results. Tumor must be HER2-negative as defined by ASCO-CAP guidelines (ref). 3. Patients starting the combination endocrine therapy + palbociclib as first or a subsequent treatment line for metastatic disease. 4. Patients must have evaluable disease as per RECIST v.1.1. 5. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study before any study-specific activity is performed.
Exclusion criteria
Exclusion criteria: 1. Pre-existing lymphedema in one or both arms, diagnosed by the treating medical oncologist 2. Patients with known hypersensitivity to the anticoagulant used for apheresis 3. Patients with inadequate cardiac function or severe cardiovascular comorbidity: - Heart failure NYHA class III/IV 4. Hemoglobin level 1.5 x ULN or PT-INR > 1.5 x ULN - APTT > 1.5 x ULN Patients with anticoagulant therapy which affects PT or APTT, when: - PT or APTT > 1.5 x the upper limit of the desired therapeutic window - Total bilirubin >2.5 x ULN 6. Known chronic viral infections 7. Patients with a history of any other cancer, unless in complete remission requiring no active treatment, are excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Newly identified and/or enriched chromosomal alterations at PD compared to baseline within 8 patients treated with palbociclib and initial disease control. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The percentage of the isolated single CTCs in which the obtained WGA product pass our quality criteria. - The percentage of the successfully whole genome amplified CTCs in which we obtain a chromosomal profile passing our quality criteria with respect to library concentration, read depth, and signal-to-noise ratio (estimated by the median absolute deviation value (MAD) of the profile) - The levels of ctDNA in patients obtained in peripheral blood before and after treatment with palbociclib | — |
Countries
Netherlands
Outcome results
None listed