Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy

NCT ID: NCT04524728

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 191 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Breast; Neoplasm Malignant; Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A

Patients that received palbociclib combined with letrozole 2.5 mg

Palbociclib

Intervention Type: DRUG

tablets

Letrozole 2.5mg

Intervention Type: DRUG

tablets

Cohort B

Patients that received palbociclib combined with fulvestrant 500 mg

Palbociclib

Intervention Type: DRUG

tablets

Fulvestrant

Intervention Type: DRUG

intramuscolar injections

Interventions

Palbociclib

tablets

Intervention Type: DRUG

Letrozole 2.5mg

tablets

Intervention Type: DRUG

Fulvestrant

intramuscolar injections

Intervention Type: DRUG

Other Intervention Names

ibrance; Femara; Faslodex

Eligibility Criteria

Inclusion Criteria

• Pre- and postmenopausal women with a histologically proven HR+MBC, candidate to receive palbociclib plus ET as first or subsequent line of therapy according to their contingent clinical situation.
• HER2- disease (IHC 0-1 or IHC 2, confirmed as FISH negative), presence of measurable or evaluable lesions and life expectancy of at least 4 months.
• Adequate bone marrow, hepatic and renal function, according to clinical practice guidelines for antineoplastic drug administration

Exclusion Criteria

• ER- PgR- disease
• HER2+ disease (IHC 3 or IHC 2, confirmed as FISH positive)
• Any cardiovascular, renal or hepatic condition that would compromise conditions in the opinion of the investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raffaella Palumbo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ICS Maugeri, IRCCS, Department of Medical Oncology, Pavia, italy

Locations

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, , Italy

Countries

Italy

Other Identifiers

CE 2295

Identifier Type: -

Identifier Source: org_study_id