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)

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02913456
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-23
• Study Start: 2016-11-16
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 629

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences	Baseline up to 8 years
Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice	Baseline up to 8 years

Secondary Outcome Measures

Name	Time	Method
Total Number of Treatment Regimens Received by Participants	Baseline up to 8 years
Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country	Baseline up to 8 years
Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens	Baseline up to 8 years
Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits	Baseline up to 8 years
Total Healthcare Cost	Baseline up to 8 years
Cost of Treating Associated AEs	Baseline up to 8 years
Overall Survival	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	Baseline up to 8 years
Resource Utilization: Percentage of Participants with Hospitalization	Baseline up to 8 years
Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice	Baseline up to 8 years
Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH])	Baseline up to 8 years
Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures	Baseline up to 8 years
Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest	Baseline up to 8 years
Percentage of Participants with HER2 Re-testing of Metastases	Baseline up to 8 years
Percentage of Participants with Change in HER2 Status	Baseline up to 8 years
EuroQol 5-Dimensions Questionnaire (EQ-5D) Score	Baseline up to 8 years
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score	Baseline up to 8 years

Trial Locations

Locations (54)

Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie; 🇦🇹 Graz, Austria

LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie; 🇦🇹 Graz, Austria

Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie; 🇦🇹 Klagenfurt, Austria

LKH Hochsteiermark; Abt. für Hämato-Onkologie; 🇦🇹 Leoben, Austria

Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT.; 🇦🇹 Linz, Austria

A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.; 🇦🇹 Ried-innkreis, Austria

A.Ö. Lhk Villach; Abt. Für Gynäkologie; 🇦🇹 Villach, Austria

Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie; 🇦🇹 Wiener Neustadt, Austria

Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie; 🇦🇹 Wien, Austria

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I; 🇦🇹 Wien, Austria

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