Neoplasm Malignant Clinical Trial
Official title:
Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy in Hormone Receptor-positive (HR+)/HER2 Receptor-negative (HER2-) Metastatic Breast Cancer (MBC): a Real World Multicentre Italian Study
This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary endpoint is the clinical benefit rate (CBR); secondary aims are the median PFS (mPFS), overall survival (OS) and safety.
This is an open-label, longitudinal, prospective, multicentre cohort study. Eligible patients
are pre- and postmenopausal women with a histologically proven HR+ MBC, candidate to receive
palbociclib plus endocrine therapy (ET) as first or subsequent line of therapy according to
their contingent clinical situation. Additional inclusion criteria are HER2- disease
(immunohistochemistry (IHC) 0-1+ or IHC 2+, confirmed as fluorescence in situ hybridization
[FISH] negative), presence of measurable or evaluable lesions and life expectancy of at least
4 months. They need to have adequate bone marrow, hepatic and renal function, according to
clinical practice guidelines for antineoplastic drug administration. Previous chemotherapy or
ET for metastatic disease is allowed. Patients receive palbociclib 125 mg daily, 3 weeks on/1
week off in a 28-day cycle, combined with letrozole 2.5 mg administered orally on a
continuous daily dosing schedule (cohort A) or fulvestrant at the dose of 500 mg
intramuscular on days 1, 14, 28, then every 4 weeks thereafter (cohort B). Premenopausal
women receive a GnRH analogue in combination with ET and palbociclib. Treatment is
administered until documented disease progression (PD), unacceptable toxicity or patient
refusal. The tumour assessment is performed approximately every 16 weeks. Treatment efficacy
is evaluated by Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). A complete
blood count and organ function test is performed before each cycle, through study completion,
an avarange of 1 year. No pre-specified treatment modifications are planned; dose reductions,
delay or discontinuations of palbociclib are performed according to observed side effects.
AEs are recorded and graded according to the National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI-CTCAE) (version 5.0).
The primary aim of the study is to analyse the activity of palbociclib plus ET in terms of
clinical benefit rate that is defined as the percentage of patients experiencing complete
response (CR), partial response (PR), or stable disease (SD) lasting 6 months or more.
Secondary aims include the evaluation of the safety of the treatments, progression-free
survival and overall survival.
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