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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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 <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists
d.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:
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 <3.0 x upper limit of normal (ULN) or <5 xULN in case of known liver metastases.
e.Alkaline phosphatase <2.5 x ULN
f.Total serum bilirubin < ULN or total bilirubin <3.0 x ULN with direct bilirubin within normal range in patients with Gilbert’s Syndrome
g.Creatinine clearance >30mL/min
h.Lipase/amylase <1/5 x ULN
i.Protrombin time, partial tromboplastin 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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