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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)

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

Study Description
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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.

Condition or disease
Breast Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 629 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 16, 2016
Estimated Primary Completion Date : December 18, 2024
Estimated Study Completion Date : December 18, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice [ Time Frame: Baseline up to 8 years ]
  2. Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences [ Time Frame: Baseline up to 8 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Baseline up to 8 years ]
  2. Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice [ Time Frame: Baseline up to 8 years ]
  3. 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 ]
  4. Total Number of Treatment Regimens Received by Participants [ Time Frame: Baseline up to 8 years ]
  5. Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest [ Time Frame: Baseline up to 8 years ]
  6. Percentage of Participants with HER2 Re-testing of Metastases [ Time Frame: Baseline up to 8 years ]
  7. Percentage of Participants with Change in HER2 Status [ Time Frame: Baseline up to 8 years ]
  8. Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH]) [ Time Frame: Baseline up to 8 years ]
  9. Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country [ Time Frame: Baseline up to 8 years ]
  10. Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens [ Time Frame: Baseline up to 8 years ]
  11. EuroQol 5-Dimensions Questionnaire (EQ-5D) Score [ Time Frame: Baseline up to 8 years ]
  12. Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score [ Time Frame: Baseline up to 8 years ]
  13. Total Healthcare Cost [ Time Frame: Baseline up to 8 years ]
  14. Cost of Treating Associated AEs [ Time Frame: Baseline up to 8 years ]
  15. Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures [ Time Frame: Baseline up to 8 years ]
  16. Resource Utilization: Percentage of Participants with Hospitalization [ Time Frame: Baseline up to 8 years ]
  17. Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits [ Time Frame: Baseline up to 8 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913456


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02913456    
Other Study ID Numbers: MO39146
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases