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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	8 April 2024
Main ID:	NCT02595762
Date of registration:	28/10/2015
Prospective Registration:	Yes
Primary sponsor:	Hoffmann-La Roche
Public title:	A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Scientific title:	A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Date of first enrolment:	October 30, 2016
Target sample size:	110
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT02595762
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Cyprus	Greece

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to
enrollment

Exclusion Criteria:

- None specified

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Locally Advanced Breast Cancer

Metastatic Breast Cancer

Intervention(s)

Primary Outcome(s)

Percentage of Participants Receiving Each Unique Treatment Regimen Sequence [Time Frame: Baseline up to approximately 8 years]

Progression-Free Survival (PFS) [Time Frame: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)]

Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy [Time Frame: Baseline up to approximately 8 years]

Percentage of Participants Receiving Each Unique Treatment Regimen Overall [Time Frame: Baseline up to approximately 8 years]

Secondary Outcome(s)

EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score [Time Frame: Baseline up to approximately 8 years]

Healthcare Resource Utilization - Indirect Disease Related Cost [Time Frame: Baseline up to approximately 8 years]

Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit [Time Frame: Baseline up to approximately 8 years]

Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities [Time Frame: Baseline up to approximately 8 years]

Healthcare Resource Utilization - Total Healthcare Cost [Time Frame: Baseline up to approximately 8 years]

Overall Survival (OS) [Time Frame: From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)]

Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score [Time Frame: Baseline up to approximately 8 years]

Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit [Time Frame: Baseline up to approximately 8 years]

Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score [Time Frame: Baseline up to approximately 8 years]

Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures [Time Frame: Baseline up to approximately 8 years]

Healthcare Resource Utilization - Length of Hospitalization [Time Frame: Baseline up to approximately 8 years]

Number of Treatment Regimens Received [Time Frame: Baseline up to approximately 8 years]

Duration of Response (DOR) [Time Frame: From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)]

Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits [Time Frame: Baseline up to approximately 8 years]

Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized [Time Frame: Baseline up to approximately 8 years]

Percentage of Participants by Reasons for Treatment Modification [Time Frame: Baseline up to approximately 8 years]

Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry [Time Frame: Baseline up to approximately 8 years]

Percentage of Participants Receiving Each Treatment Regimen, by Country/Region [Time Frame: Baseline up to approximately 8 years]

Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics [Time Frame: Baseline up to approximately 8 years]

Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [Time Frame: Baseline up to approximately 8 years]

Percentage of Participants With Complete Response (CR) or Partial Response (PR) - Objective Response Rate (ORR) [Time Frame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)]

Percentage of Participants With HER2 Retesting [Time Frame: Baseline up to approximately 8 years]

Secondary ID(s)

ML28801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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