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)

Terminated

• Conditions: Metastatic Breast Cancer
• Interventions: Other: No intervention

• Registration Number: NCT02611310
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Study Start: 2017-01-19
• Primary Completion: 2018-11-12
• Study Completion: 2018-11-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

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Exclusion Criteria

None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with HER2-positive unresectable LA/mBC	No intervention	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Quality of Life, as Assessed by the EuroQol 5-Dimensions Questionnaire (EQ-5D)	Up to 5 years
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
Duration of Response (DoR) Per Anti-Cancer Treatment Regimen	Up to 5 years
Overall Health Status, as Assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B)	Up to 5 years

Trial Locations

Locations (3)

National Guard King Abdulaziz Medical City; Oncology; 🇸🇦 Riyadh, Saudi Arabia

King Abdullah Medical City-Holy Makkah; 🇸🇦 Holy Makkah, Saudi Arabia

King Fahad Medical City; Gastroentrology; 🇸🇦 Riyadh, Saudi Arabia