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)

January 6, 2020 updated by: Hoffmann-La Roche

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Holy Makkah, Saudi Arabia, 21583-Makkah P.O.Box-53356
        • King Abdullah Medical City-Holy Makkah
      • Riyadh, Saudi Arabia, 11426
        • National Guard King Abdulaziz Medical City; Oncology
      • Riyadh, Saudi Arabia, 11525
        • King Fahad Medical City; Gastroentrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with HER2-positive unresectable LA/mBC

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with HER2-positive unresectable LA/mBC
Other: No intervention
No intervention administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 5 years
Up to 5 years
Number of Participants With Adverse Events
Time Frame: Up to 5 years
Up to 5 years
Objective Response Rate (ORR) Per Anti-Cancer Treatment Regimen
Time Frame: Up to 5 years
Up to 5 years
Duration of Response (DoR) Per Anti-Cancer Treatment Regimen
Time Frame: Up to 5 years
Up to 5 years
Quality of Life, as Assessed by the EuroQol 5-Dimensions Questionnaire (EQ-5D)
Time Frame: Up to 5 years
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
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2017

Primary Completion (Actual)

November 12, 2018

Study Completion (Actual)

November 12, 2018

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29618

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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