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

Early identification of patients who benefit from palbociclib in addition to letrozole - Palbociclib and FES PET

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46198

Enrollment

Registered

2016-03-29

Start date

2016-09-16

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic breast cancer

Interventions

1 FES PET 1 FDG PET palbociclib

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1. Life expectancy

Design outcomes

Primary

Measure	Time frame
The relation between low uptake on FES-PET to response per lesion, as measured by RECIST 1.1 criteria in case of measurable disease (1). In case of non-measurable bone lesions, progression is defined as an increase in SUV on FDG-PET per lesion compared to baseline. It is hypothesized that lesions with a low uptake on FES-PET will not respond to letrozole plus palbociclib. When in at least 85% of the lesions with no response on treatment, also a low uptake (tumor SUV of	—

Measure

Time frame

The relation between low uptake on FES-PET to response per lesion, as measured by RECIST 1.1 criteria in case of measurable disease (1). In case of non-measurable bone lesions, progression is defined as an increase in SUV on FDG-PET per lesion compared to baseline. It is hypothesized that lesions with a low uptake on FES-PET will not respond to letrozole plus palbociclib. When in at least 85% of the lesions with no response on treatment, also a low uptake (tumor SUV of

—

Secondary

Measure	Time frame
Descriptive analysis of quantitative FES-uptake and correlation with progression free survival. Descriptive analysis of circulating tumor DNA and correlation with FES-PET results and progression free survival. 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	—

Measure

Time frame

Descriptive analysis of quantitative FES-uptake and correlation with progression free survival. Descriptive analysis of circulating tumor DNA and correlation with FES-PET results and progression free survival. 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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)