Palbociclib and FES PET

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose is to evaluate whether non invasive in vivo imaging of the estrogen receptor (ER) presence in metastatic breast cancer patient by means of 18F-fluoro-estradiol (FES) positron emission tomography (PET) can be used to predict treatment response to palbociclib plus letrozole. As ER expression predicts response to palbociclib in metastatic breast cancer patients the investigators hypothesize that lesions with low uptake on FES-PET will not respond to the combination of letrozole plus palbociclib.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Letrozole; Palbociclib

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:

• Age ≥60 years

• Previous bilateral oophorectomy

• Age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists

• Age <60 years using ER antagonists should have amenorrhea for >12 months and FSH >24U/L and LH>14U/L

3. Adequate bone marrow and organ function defined as follows:

• Absolute neutrophil count > 1.5 x 109/L

• Platelet count >100 x 109/L

• White blood cell count >3 x 109/L

• AST and ALT <3.0 x upper limit of normal (ULN) or <5 xULN in case of known liver metastases.

• Alkaline phosphatase <2.5 x ULN

• Total serum bilirubin < ULN or total bilirubin <3.0 x ULN with direct bilirubin within normal range in patients with Gilbert's Syndrome

• Creatinine clearance >50mL/min

• Lipase/amylase <1/5 x ULN

• Prothrombin time, partial thromboplastin time and INR <1.5 x ULN

4. ECOG performance 0-2

5. Signed written informed consent

6. Able to comply with the protocol

7. Age ≥18 years

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

9. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of treatment that are known strong inducers or inhibitors of CYP3A4/5, known risk to prolong the QT interval or induce Torsades de Pointes, or narrow therapeutic window and are predominantly metabolized through CYP3A4/5.