NCT02616224

Brief Summary

This observational disease registry is a prospective, national, non-interventional study designed to enroll participants who have received an initial diagnosis of unresectable, locally advanced (LA) or metastatic breast cancer (mBC), up to 6 months prior to registry enrolment. These participants will be prospectively followed for at least 5 years after study enrolment 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

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Status
withdrawn

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
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

9.3 years

First QC Date

November 19, 2015

Last Update Submit

February 22, 2017

Conditions

Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS) For Each Anti-Cancer Treatment Regimen

    Up to approximately 8 years

Secondary Outcomes (3)

  • Overall Survival (OS)

    Up to approximately 8 years

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

    Up to approximately 8 years

  • Number and Percentage of Participants Receiving Each Unique Treatment Regimen Overall and as First-Line Therapy Versus Second-Line Therapy Versus Subsequent-Line Therapy

    Up to approximately 8 years

Study Arms (1)

Participants with unresectable LA/mBC

Other: No intervention

Interventions

No interventionOTHER

No intervention was administered in this study.

Participants with unresectable LA/mBC

Eligibility Criteria

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

Participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrolment.

You may qualify if:

  • \- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrolment, although they can have received anti-cancer treatment during that time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
0

Study Design

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

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 26, 2015

Study Start

September 1, 2016

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 23, 2017

Record last verified: 2017-02