The use of single cell genomics to identify chromosomal alterations driving resistance to palbociclib in metastatic breast cancer patients
- Conditions
- Metastatic breast cancer10006291
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
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.
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;
Patients without anticoagulant therapy which affects PT or APTT, when:
- PT > 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Newly identified and/or enriched chromosomal alterations at PD compared to<br /><br>baseline within 8 patients treated with palbociclib and initial disease<br /><br>control. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- The percentage of the isolated single CTCs in which the obtained WGA product<br /><br>pass our quality criteria.<br /><br>- The percentage of the successfully whole genome amplified CTCs in which we<br /><br>obtain a chromosomal profile passing our quality criteria with respect to<br /><br>library concentration, read depth, and signal-to-noise ratio (estimated by the<br /><br>median absolute deviation value (MAD) of the profile)<br /><br>- The levels of ctDNA in patients obtained in peripheral blood before and after<br /><br>treatment with palbociclib</p><br>