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)

Metastatic Breast Cancer Clinical Trial

Official title:

Saudi Arabia - A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02611310
• Other study ID #: ML29618
• Status: Terminated
• Start date: January 19, 2017
• Est. completion date: November 12, 2018

Study information

• Verified date: January 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 12, 2018
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Other:
• No intervention
No intervention administered in this study.

Locations

Country	Name	City	State
Saudi Arabia	King Abdullah Medical City-Holy Makkah	Holy Makkah
Saudi Arabia	King Fahad Medical City; Gastroentrology	Riyadh
Saudi Arabia	National Guard King Abdulaziz Medical City; Oncology	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)		Up to 5 years
Secondary	Number of Participants With Adverse Events		Up to 5 years
Secondary	Overall Survival (OS)		Up to 5 years
Secondary	Objective Response Rate (ORR) Per Anti-Cancer Treatment Regimen		Up to 5 years
Secondary	Duration of Response (DoR) Per Anti-Cancer Treatment Regimen		Up to 5 years
Secondary	Quality of Life, as Assessed by the EuroQol 5-Dimensions Questionnaire (EQ-5D)		Up to 5 years
Secondary	Overall Health Status, as Assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B)		Up to 5 years