Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Evaluation of patient-reported outcomes

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Prospective, multicenter longitudinal study
Study drug and medical condition

Name of medicine

IBRANCE

Medical condition to be studied

Breast cancer stage IV
Population studied

Short description of the study population

Two independent patient groups were included in the study for the purpose of describing the experiences of those on palbociclib and those on other treatments for aBC/mBC:
Group 1: Patients initiating palbociclib treatment
- Approximately 150 to 300 women with HR+/HER2− aBC/mBC who were initiating
o P+AI as initial endocrine-based therapy for postmenopausal women with aBC/mBC per label; OR
o P+Ful for patients with disease progression following endocrine therapy for aBC/mBC per label
Group 2: Patients with aBC/mBC initiating first-, second-, or third-line treatment with any regimen other than those containing palbociclib
- Approximately 150 patients who were initiating treatment with any regimen other than those containing palbociclib for aBC/mBC in first, second, or third lines of treatment
Inclusion Criteria
Patients must have met all of the following inclusion criteria to be eligible for the study:
- Owned or had regular access to an Apple iPhone (version 5.0 or higher with latest software: iOS 9.0 or higher) or Android phone (e.g., Nexus or Galaxy with latest
software: version 4.4.2 or higher).
- Adult women (≥ 18 years of age) with diagnosis of adenocarcinoma of the breast with evidence of mBC/aBC not amenable to resection or radiation therapy with curative intent
- Documented evidence of HR+ tumor based on the patient’s most recent tumor biopsy.
- Documented evidence of an HER2− tumor based on the patient’s most recent tumor biopsy. HER2− was determined as an immunohistochemistry score of 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17 ratio < 2 or, for single probe assessment, a HER2 copy number < 4).
- Initiating first-, second-, or third-line treatment with one of the following therapies: P+AI as initial endocrine-based therapy for postmenopausal women with aBC/mBC as per label, or P+Ful if the patient had experienced disease progression following endocrine therapy as per label, or other approved therapy as the first treatment for aBC/mBC, or initiating other approved therapy as the second or third treatment for aBC/mBC.
- Evidence of a personally signed and dated informed consent form document indicating that the patient had been informed of all pertinent aspects of the study.
- Able to read and understand English
- Willing and able to complete collection of data via mobile app.

Exclusion Criteria
Patients meeting any of the following criteria were not included in the study:
- Patient was initiating neoadjuvant systemic therapy.
- In the judgment of the investigator, the patient’s life expectancy was fewer than 3 months at the time of diagnosis of aBC/mBC.
- The patient was participating in any interventional clinical trial that included investigational or marketed products. Patients participating in other investigator-initiated research or non-interventional studies could be included as long as their standard of care was not altered by the study.
- The patient was on active treatment for other malignancies other than aBC/mBC.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Breast Cancer patients

Estimated number of subjects

175
Study design details

Main study objective

The primary objectives of this prospective non-interventional study (NIS) are to assess and describe patient-reported outcomes (PROs) in women with locally advanced/unresectable or metastatic (ABC/mBC) HR+/HER2– breast cancer receiving:1) IBRANCE in combination with letrozole or fulvestrant as per product label (GROUP 1) or2) Approved therapies for ABC/mBC other than IBRANCE (GROUP 2)

Data analysis plan

Descriptive analyses only, no hypotheses being tested
Documents
Study results

A5481074 Non-Interventional Final Study Report_Final v1.0_24AUG2020

English (8.96 MB - PDF)View document
Study publications
Richardson D, Zhan L, Mahtani R, McRoy L, Mitra D, Reynolds M, Odom D, Hollis K…