A Study to Observe Treatment Patterns and Outcomes in Participants in Saudi Arabia With Human Epidermal Growth Factor Receptor 2 (HER2-Positive) Unresectable Locally Advanced or Metastatic Breast Cancer (LA/mBC)

Hoffmann-La Roche15 enrolled

Overview

This is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment. These participants will be prospectively followed for at least 5 years after study enrollment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

No interventionOTHER

No intervention administered in this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment * Able to comply with the study protocol Exclusion Criteria: None

Locations (3)

King Abdullah Medical City-Holy Makkah

Holy Makkah, Saudi Arabia

National Guard King Abdulaziz Medical City; Oncology

Riyadh, Saudi Arabia

King Fahad Medical City; Gastroentrology

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Time frame: Up to 5 years

Secondary Outcomes

Number of Participants With Adverse Events

Time frame: Up to 5 years

Overall Survival (OS)

Time frame: Up to 5 years

Objective Response Rate (ORR) Per Anti-Cancer Treatment Regimen

Time frame: Up to 5 years

Duration of Response (DoR) Per Anti-Cancer Treatment Regimen

Time frame: Up to 5 years

Quality of Life, as Assessed by the EuroQol 5-Dimensions Questionnaire (EQ-5D)

Time frame: Up to 5 years

Overall Health Status, as Assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B)

Time frame: Up to 5 years