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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)

This study has been terminated.
(Study was prematurely terminated because of missing data collection.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01187381
First Posted: August 24, 2010
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention
Breast Cancer Drug: Trastuzumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Treatment Duration With Trastuzumab in the Routine Clinical Practice [ Time Frame: Baseline up to 5 years ]

Secondary Outcome Measures:
  • Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation [ Time Frame: 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.

  • 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).

  • Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer [ Time Frame: 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.

  • Percentage of Participants by the Site of First Disease Progression [ Time Frame: Baseline up to 5 years ]

Enrollment: 250
Actual Study Start Date: April 14, 2010
Study Completion Date: October 15, 2015
Primary Completion Date: October 15, 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Herceptin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female participants with early or metastatic HER2-positive breast cancer
Criteria

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
  Contacts and Locations
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): NCT01187381


Locations
Romania
Cluj Clinical County Hospital; Oncology Dept
Cluj-Napoca, Romania, 400006
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01187381     History of Changes
Other Study ID Numbers: ML25235
First Submitted: August 20, 2010
First Posted: August 24, 2010
Results First Submitted: May 30, 2017
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents