Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy

NCT04524728 | Completed

• 1 other identifier: CE 2295
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast; Neoplasm Malignant; Female

Keywords

endocrine therapy; metastatic breast cancer; palbociclib; real world; visceral involvement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Median PFS

  From date of randomization until the date of first documented progression, assessed up to 16 weeks through study completion

• Overall survival

  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.

• Drug safety and tolerability

  at day 1 of any cycle from the date of the start of therapy through study completion, an avarange of 1 year

Study Arms (2)

Cohort A

Patients that received palbociclib combined with letrozole 2.5 mg

Drug: Palbociclib; Drug: Letrozole 2.5mg

Cohort B

Patients that received palbociclib combined with fulvestrant 500 mg

Drug: Palbociclib; Drug: Fulvestrant

Interventions

Palbociclib DRUG

tablets

Also known as: ibrance

Cohort A; Cohort B

Letrozole 2.5mg DRUG

tablets

Also known as: Femara

Cohort A

Fulvestrant DRUG

intramuscolar injections

Also known as: Faslodex

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

One hundred-ninety-one patients (92 in cohort A, 99 in cohort B) were enrolled and treated and 182 were evaluable for the analysis. Median age was 62 years (range 47-79)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms

Interventions

palbociclib; Letrozole; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Raffaella Palumbo, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 100 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: August 24, 2020
• Study Start: December 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-07

Locations

IT (1)