Metastatic Breast Cancer
Conditions
Brief summary
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.
Interventions
OTHERNo intervention
No intervention administered in this study.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to 5 years |
| Objective Response Rate (ORR) Per Anti-Cancer Treatment Regimen | Up to 5 years |
| Number of Participants With Adverse Events | Up to 5 years |
| Quality of Life, as Assessed by the EuroQol 5-Dimensions Questionnaire (EQ-5D) | Up to 5 years |
| Overall Health Status, as Assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) | Up to 5 years |
| Duration of Response (DoR) Per Anti-Cancer Treatment Regimen | Up to 5 years |
Countries
Saudi Arabia
Outcome results
None listed