NL-OMON52225
Recruiting
Not Applicable
The use of single cell genomics to identify chromosomal alterations driving resistance to palbociclib in metastatic breast cancer patients - PALETTE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 48
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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\.
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 \< 6\.0 mmol/L
- •5\. Coagulation disorders as defined by one of the following
- •\- Coagulation disorder in medical history
- •\- Platelet count \< 40 x 109/L;
Outcomes
Primary Outcomes
Not specified
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