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)

• ClinicalTrials.gov Identifier: NCT02913456
• Recruitment Status: Active, not recruiting
• First Posted: September 23, 2016
• Last Update Posted: June 22, 2022
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: September 22, 2016
• First Posted Date: September 23, 2016
• Last Update Posted Date: June 22, 2022
• Actual Study Start Date: November 16, 2016
• Estimated Primary Completion Date: December 18, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 22, 2016)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 22, 2016)

• 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]) [ Time Frame: Baseline up to 8 years ]
• Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country [ Time Frame: Baseline up to 8 years ]
• Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens [ Time Frame: Baseline up to 8 years ]
• EuroQol 5-Dimensions Questionnaire (EQ-5D) Score [ Time Frame: Baseline up to 8 years ]
• Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score [ Time Frame: Baseline up to 8 years ]
• Total Healthcare Cost [ Time Frame: Baseline up to 8 years ]
• Cost of Treating Associated AEs [ Time Frame: Baseline up to 8 years ]
• Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures [ Time Frame: Baseline up to 8 years ]
• Resource Utilization: Percentage of Participants with Hospitalization [ Time Frame: Baseline up to 8 years ]
• Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits [ Time Frame: Baseline up to 8 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• Official Title: A European Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Participants initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
• Condition: Breast Cancer
• Intervention: Not Provided

Study Groups/Cohorts

HER2-positive unresectable LA/mBC

Participants with HER2-positive unresectable LA/mBC diagnosed up to 6 months prior to enrollment will be included in the study. Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LA/mBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 23, 2022): 629
• Original Estimated Enrollment (submitted: September 22, 2016): 465
• Estimated Study Completion Date: December 18, 2024
• Estimated Primary Completion Date: December 18, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Bulgaria, Italy, Portugal, Romania

Administrative Information

• NCT Number: NCT02913456
• Other Study ID Numbers: MO39146
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hoffmann-La Roche
• Original Responsible Party: Same as current
• Current Study Sponsor: Hoffmann-La Roche
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: June 2022