Early identification of patients who benefit from palbociclib in addition to letrozole

Phase 2

Completed

Conditions: Metastatic breast cancer
10027476

Registration Number: NL-OMON46198

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Patients with ER positive (i.e. >1% staining), HER2 negative metastatic breast cancer
2. Post-menopausal status
3. Adequate bone marrow and organ function
4. ECOG performance 0-2
5. Signed written informed consent
6. Able to comply with the protocol
7. Age >=18 years

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The relation between low uptake on FES-PET to response per lesion, as measured<br /><br>by RECIST 1.1 criteria in case of measurable disease (1). In case of<br /><br>non-measurable bone lesions, progression is defined as an increase in SUV on<br /><br>FDG-PET per lesion compared to baseline.<br /><br>It is hypothesized that lesions with a low uptake on FES-PET will not respond<br /><br>to letrozole plus palbociclib. When in at least 85% of the lesions with no<br /><br>response on treatment, also a low uptake (tumor SUV of <1.5) on baseline<br /><br>FES-PET is observed, we consider that FES-PET can be evaluated in further,<br /><br>larger studies as a potential predictive biomarker. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Descriptive analysis of quantitative FES-uptake and correlation with<br /><br>progression free survival.<br /><br>Descriptive analysis of circulating tumor DNA and correlation with FES-PET<br /><br>results and progression free survival.<br /><br>Predictive value of change in FDG uptake per lesion (baseline compared to 2<br /><br>week scan) for response after 8 weeks (measured by CT or FDG PET in case of<br /><br>bone lesions).<br /><br>Per patient analysis of response on CT related to change on FDG PET (baseline-2<br /><br>weeks) and FES uptake at baseline</p><br>