An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer

Roche

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02286362

ML28983

Details and patient eligibility

About

This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.

Enrollment: 510 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged >/= 18 years
• Patients with HER2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant HER2+ treatment
• Patients for whom the investigator has decided to start a treatment with Herceptin SC
• Trastuzumab treatment naive or non-naive (previously intravenous treatment)
• Informed consent

Exclusion criteria

• Patients previously treated with Herceptin SC treatment

Trial design

510 participants in 1 patient group

Cohort