Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.

Pfizer

Status: Completed

Conditions: Breast Cancer Metastatic

Study type: Observational

Funder types: Industry

Identifiers

NCT05155566

IRIS LATAM (Other Identifier)

A5481125

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 as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.

Enrollment: 847 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Physician inclusion criteria:

• Oncologist or gynecologist.
• Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria.
• Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period.

Patient inclusion criteria:

• HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
• Received palbociclib as a first line therapy.
• No prior or current enrolment in an interventional clinical trial for ABC/MBC.
• Minimum of six months of follow up data since palbociclib initiation.

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 as first line therapy.

Trial design

847 participants in 1 patient group

Breast Cancer Patients

Description:

HR + /HER2- Advanced/Metastatic Breast Cancer patients in Latin America