An Observational Study of the Mean Duration of Herceptin (Trastuzumab) Treatment in Patients With Early or Metastatic HER2-positive Breast Cancer (HERODOT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01187381
First received: August 20, 2010
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

This single arm observational study will assess the duration and safety of treatment with Herceptin (trastuzumab) in routine clinical practice in patients with early or metastatic HER2-positive breast cancer. Data will be collected from female patients treated with Herceptin according to the Summary of Product Characteristics and local protocols. Duration of observation for each patient is from therapy initiation until permanent discontinuation for any cause.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter, Single-arm, Observational Study of Mean Duration of Trastuzumab Treatment for Early and Metastatic Breast Cancer in Romanian Population (HERODOT Study)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean duration of Herceptin treatment in routine clinical practice, from start of treatment to permanent discontinuation [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reasons for discontinuation of Herceptin therapy [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Safety: Adverse events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Therapeutic strategies before and during Herceptin treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Progression-free survival in metastatic breast cancer [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Site of first disease progression during Herceptin therapy in metastatic setting [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Female patients with early or metastatic HER2-positive breast cancer

Criteria

Inclusion Criteria:

  • Female patients, >/= 18 years of age
  • HER2-positive breast cancer
  • Treated with Herceptin in accordance with Summary of Product Characteristics and local protocols
  • Written informed consent to data collection

Exclusion Criteria:

  • Any contraindication to Herceptin
  • Clinically relevant cardiovascular disorder or disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187381

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01187381     History of Changes
Other Study ID Numbers: ML25235
Study First Received: August 20, 2010
Last Updated: December 3, 2013
Health Authority: Romania: National Medicines Agency

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014