estrogen receptor positive metastatic breast cancer patients eligible for palbociclib plus letrozole treatment
Conditions
Interventions
Product Name: 18F-FES
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 18F-FES
Other descriptive name: 16?-[18F]FLUORO-17?-ESTRADIOL
Concentration unit: MBq megabecquerel(s)
Concentrat
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Patients with ER positive (i.e. >1% staining), HER2 negative metastatic breast cancer (preferably assessment on fresh metastasis biopsy, alternatively archival metastasis biopsy) 2. Post-menopausal status defined as: a. Age =60 years b. Previous bilateral oophorectomy c. Age 12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists d. Age 12 months and FSH >24U/L and LH>14U/L 3. Adequate bone marrow and organ function defined as follows: a. Absolute neutrophil count > 1.5 x 109/L b. Platelet count >100 x 109/L c. White blood cell count >3 x 109/L d. AST and ALT 30mL/min h. Lipase/amylase =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Life expectancy < 3 months 2. Evidence of central nervous system metastases 3. Presence of life-threatening visceral metastases 4. Prior use of CDK4/6 inhibitor 5. Use of estrogen receptor ligands including estrogens, fulvestrant or tamoxifen <6 weeks before study entry. 6. Use of other anticancer therapy < 2 weeks prior to start with palbociclib 7. Concurrent malignancy 8. Active cardiac disease or a history of cardiac dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate in a feasibility study whether low uptake on FES-PET at baseline is related to non response to letrozole plus palbociclib treatment.;Primary end point(s): The relation between low uptake on FES-PET to response per lesion, as measured by RECIST 1.1 criteria in case of measurable disease. In case of non-measurable bone lesions, progression is defined as an increase in SUV on FDG-PET per lesion compared to baseline. ;Timepoint(s) of evaluation of this end point: 8 weeks;Secondary Objective: To assess heterogeneity in tumor ER expression To relate circulating tumor DNA analysis at baseline to all other molecular, imaging and clinical follow-up data Predictive value of change in FDG uptake per lesion (baseline compared to 2 week scan) for response after 8 weeks (measured by CT or FDG PET in case of bone lesions). Per patient analysis of response on CT related to change on FDG PET (baseline-2 weeks) and FES uptake at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess heterogeneity in tumor ER expression To relate circulating tumor DNA analysis at baseline to all other molecular, imaging and clinical follow-up data Predictive value of change in FDG uptake per lesion (baseline compared to 2 week scan) for response after 8 weeks (measured by CT or FDG PET in case of bone lesions). Per patient analysis of response on CT related to change on FDG PET (baseline-2 weeks) and FES uptake at baseline.;Timepoint(s) of evaluation of this end point: at time of progression | — |
Countries
Netherlands
Contacts
Public ContactCP Schröder
University Medical Center Groningen
Outcome results
None listed