H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer

Roche

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01991340

ML21975

Details and patient eligibility

About

This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.

Enrollment: 657 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Histologically confirmed HER2-positive breast cancer
• Eligible to receive Herceptin as per Summary of Product Characteristics

Exclusion criteria

• Contra-indications according to Summary of Product Characteristics

Trial design

657 participants in 1 patient group

Cohort