Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524728
• Other study ID #: CE 2295
• Status: Completed
• Start date: December 2016
• Est. completion date: June 2020

Study information

• Verified date: July 2020
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: June 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast
• Female
• Neoplasm Malignant
• Neoplasms

Intervention

Drug:
• Palbociclib
tablets
• Letrozole 2.5mg
tablets
• Fulvestrant
intramuscolar injections

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri IRCCS	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Benefit Rate (CBR)	the percentage of patients experiencing complete response (CR), partial response (PR), or stable disease (SD) lasting 6 months or more	From the date of randomization through study completion, assessed up to 16 weeks
Secondary	Median PFS	the time interval from the start of therapy with palbociclib plus ET to the date of	From date of randomization until the date of first documented progression, assessed up to 16 weeks through study completion
Secondary	Overall survival	the interval from therapy start to the date of death or of last follow-up evaluation	from the date of randomization until the date of death from any cause or lost of follow-up, whichever came first, assessed up to 100 months.
Secondary	Drug safety and tolerability	Incidence of Treatment-emergent adverse events (safety and tolerability) using CTCAE criteria	at day 1 of any cycle from the date of the start of therapy through study completion, an avarange of 1 year