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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 20, 2010
Last updated: October 13, 2014
Last verified: October 2014

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

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: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)


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


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 identifier: NCT01187381

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

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01187381     History of Changes
Other Study ID Numbers: ML25235
Study First Received: August 20, 2010
Last Updated: October 13, 2014
Health Authority: Romania: National Medicines Agency

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on October 16, 2014