Observational Study of Pertuzumab Safety in Participants With Breast Cancer

Roche

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Pertuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02266173

ML29299

Details and patient eligibility

About

This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 1000 participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-human epidermal growth factor receptor 2 (HER2) therapy for their metastatic disease with HER2 positivity in Korea. Participants who are administered with pertuzumab according to medical opinions of the doctor in charge of surveillance will be registered for this study and treated with pertuzumab under the approval conditions of the product in Korea.

Enrollment: 1,130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-HER2 therapy for metastatic disease with HER2 positivity
• HER2-positive, locally advanced, inflammatory, or early stage breast cancer (greater than [>]2 centimeters [cm] in diameter) participants who have never received chemotherapy and surgery for breast cancer

Exclusion criteria

• Hypersensitivity for pertuzumab (Perjeta) or any of its excipients
• Contraindications to Perjeta according to SmPC
• Pregnancy and lactation

Trial design

1,130 participants in 1 patient group

Pertuzumab

Description:

Participants for whom the treating physician has decided to administer pertuzumab according to standard of care and in line with the current summary of product characteristics (SmPC)/local labeling, will be observed.

Treatment:

Drug: Pertuzumab