NCT02611310

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 19, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2018

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

November 19, 2015

Last Update Submit

January 6, 2020

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    Up to 5 years

Secondary Outcomes (6)

  • Number of Participants With Adverse Events

    Up to 5 years

  • Overall Survival (OS)

    Up to 5 years

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

    Up to 5 years

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

    Up to 5 years

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

    Up to 5 years

  • +1 more secondary outcomes

Study Arms (1)

Participants with HER2-positive unresectable LA/mBC

Other: No intervention

Interventions

No interventionOTHER

No intervention administered in this study.

Participants with HER2-positive unresectable LA/mBC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with HER2-positive unresectable LA/mBC

You may qualify if:

  • Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
  • Able to comply with the study protocol

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

King Abdullah Medical City-Holy Makkah

Holy Makkah, 21583-Makkah P.O.Box-53356, Saudi Arabia

Location

National Guard King Abdulaziz Medical City; Oncology

Riyadh, 11426, Saudi Arabia

Location

King Fahad Medical City; Gastroentrology

Riyadh, 11525, Saudi Arabia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 20, 2015

Study Start

January 19, 2017

Primary Completion

November 12, 2018

Study Completion

November 12, 2018

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

SA(3)