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)

Roche

Status: Terminated

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01187381

ML25235

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Participants with Breast Cancer

Description:

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.

Treatment:

Drug: Trastuzumab