- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01187381
An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (HERODOT)
May 30, 2017 updated by: Hoffmann-La Roche
Multicenter, Single-Arm, Observational Study of Mean Duration of Trastuzumab (Herceptin) Treatment in Patients With HER2-Positive Early or Metastatic Breast Cancer in Romanian Population
This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer.
Data will be collected from female participants treated with trastuzumab according to the Summary of Product Characteristics and local protocols.
Duration of observation for each participant is from therapy initiation until permanent discontinuation for any cause.
Study Overview
Study Type
Observational
Enrollment (Actual)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cluj-Napoca, Romania, 400006
- Cluj Clinical County Hospital; Oncology Dept
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female participants with early or metastatic HER2-positive breast cancer
Description
Inclusion Criteria:
- HER2-positive breast cancer
- Treated with trastuzumab in accordance with Summary of Product Characteristics and local protocols
- Written informed consent to data collection
Exclusion Criteria:
- Any contraindication to trastuzumab
- Clinically relevant cardiovascular disorder or disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Participants with Breast Cancer
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, will be observed.
Dosing and treatment duration of the trastuzumab will be at the discretion of the treating physician.
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Trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment Duration With Trastuzumab in the Routine Clinical Practice
Time Frame: Baseline up to 5 years
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Baseline up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
Time Frame: Baseline up to 5 years
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Baseline up to 5 years
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Percentage of Participants Who Received Previous Neoadjuvant Therapy
Time Frame: Baseline up to 5 years
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As a neoadjuvant therapy, participants received chemotherapy alone, radiotherapy alone, hormonal therapy alone or combination of these therapies.
Percentage of participants who received these therapies is reported.
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Baseline up to 5 years
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Percentage of Participants Who Had Surgical Procedure for Breast Cancer
Time Frame: Baseline up to 5 years
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Percentage of participants who underwent different types of surgical procedures for breast cancer are reported.
Different types of surgical procedures included: breast-conserving surgery; mastectomy; and other (any other surgical procedure except breast-conserving surgery and mastectomy).
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Baseline up to 5 years
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Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer
Time Frame: Baseline up to 5 years
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Baseline up to 5 years
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Progression Free Survival
Time Frame: Baseline uo tp 5 years
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Progression free survival was defined as the time from first dose of trastuzumab to disease progression as assessed by treating physician.
Due to observational nature of the study, there was no specific method of assessment used to define progressive disease.
Progressive disease was confirmed by treating physician, based on his/her assessment according to local practice.
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Baseline uo tp 5 years
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Percentage of Participants by the Site of First Disease Progression
Time Frame: Baseline up to 5 years
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Baseline up to 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 14, 2010
Primary Completion (Actual)
October 15, 2015
Study Completion (Actual)
October 15, 2015
Study Registration Dates
First Submitted
August 20, 2010
First Submitted That Met QC Criteria
August 20, 2010
First Posted (Estimate)
August 24, 2010
Study Record Updates
Last Update Posted (Actual)
October 20, 2017
Last Update Submitted That Met QC Criteria
May 30, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML25235
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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