A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)

N/ACompletedNCT02913456

Hoffmann-La Roche629 enrolled

Overview

This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment.

Study Type

OBSERVATIONAL

Enrollment

629

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time Exclusion Criteria: \- Not applicable

Locations (54)

Outcomes

Primary Outcomes

Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice

Time frame: Baseline up to 8 years

Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences

Time frame: Baseline up to 8 years

Secondary Outcomes

Overall Survival

Time frame: Baseline up to 8 years

Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice

Time frame: Baseline up to 8 years

Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice

Time frame: Baseline up to 8 years

Total Number of Treatment Regimens Received by Participants

Time frame: Baseline up to 8 years

Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest

Time frame: Baseline up to 8 years

Percentage of Participants with HER2 Re-testing of Metastases

Time frame: Baseline up to 8 years

Percentage of Participants with Change in HER2 Status

Time frame: Baseline up to 8 years

Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH])

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

NCT02913456 - A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA) | Crick | Crick