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A Study To Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02616224
Enrollment
0
Registered
2015-11-26
Start date
2016-09-30
Completion date
2025-12-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERNo intervention

No intervention was administered in this study.

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- 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

Exclusion criteria

There are no

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS) For Each Anti-Cancer Treatment RegimenUp to approximately 8 years

Secondary

MeasureTime frame
Overall Survival (OS)Up to approximately 8 years
Objective Response Rate (ORR) For Each Anti-Cancer Treatment RegimenUp 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 TherapyUp to approximately 8 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026