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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 : March 24, 2022
Sponsor:
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 March 24, 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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date March 2022