Ibrance Real World Insights (IRIS)

Pfizer

Status: Completed

Conditions: Malignant Neoplasm of Breast

Study type: Observational

Funder types: Industry

Identifiers

NCT03159195

A5481090

IRIS

Details and patient eligibility

About

To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.

Enrollment: 652 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Physician inclusion criteria

• Oncologist or gynecologist
• Responsible for treating a minimum of ≥2-6 (depending on country) ABC/MBC patients who meet the eligibility criteria.
• Agrees to participate in the study and complete the eCRFs within the data collection period.

Patient inclusion criteria

• Female
• ≥18 years old.
• HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
• Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s).
• No prior or current enrolment in an interventional clinical trial for ABC/MBC.
• Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review).
• Minimum of three months of follow up data since palbociclib initiation (German interim medical record review only).
• Inoperable or recurrent breast cancer (Japan only)

Exclusion criteria:

Physician exclusion criteria

• Qualified less than 2 years ago or more than 35 years ago
• Participated in observational research for ABC/MBC in the last 3 months
• Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor in line with the licenced indication(s).

Trial design

652 participants in 1 patient group

Breast Cancer Patients

Description:

HR+/HER2- advanced/metastatic breast cancer patients across multiple countries.