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

Status

Terminated

Conditions

Intervention / Treatment

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

  • Romania
      • Cluj-Napoca, Romania, 400006
        • Cluj Clinical County Hospital; Oncology Dept

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
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.
Drug: Trastuzumab
Trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines
Other Names:
  • Herceptin

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
Baseline up to 5 years

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
Baseline up to 5 years
Percentage of Participants Who Received Previous Neoadjuvant Therapy
Time Frame: Baseline up to 5 years
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.
Baseline up to 5 years
Percentage of Participants Who Had Surgical Procedure for Breast Cancer
Time Frame: Baseline up to 5 years
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).
Baseline up to 5 years
Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer
Time Frame: Baseline up to 5 years
Baseline up to 5 years
Progression Free Survival
Time Frame: Baseline uo tp 5 years
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.
Baseline uo tp 5 years
Percentage of Participants by the Site of First Disease Progression
Time Frame: Baseline up to 5 years
Baseline up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

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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