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Observational Study of Pertuzumab Safety in Participants With Breast Cancer
Observational Study of Pertuzumab Safety in Participants With Breast Cancer

NCT02266173

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Pertuzumab

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (37)
  • Busan, South Korea
  • Busan, South Korea
  • Busan, South Korea
  • Daegu, South Korea
  • Daegu, South Korea
  • Daejeon, South Korea
  • Gyeonggi-do, South Korea
  • Gyeonggi-do, South Korea
  • Gyeonggi-do, South Korea
  • Gyeonggi-do, South Korea
  • Gyeonggi-do, South Korea
  • Gyeonggi-do, South Korea
  • Gyeongsangnam-do, South Korea
  • Incheon, South Korea
  • Incheon, South Korea
  • Incheon, South Korea
  • Incheon, South Korea
  • Jeollanam-do, South Korea
  • Jeonlabuk-do, South Korea
  • Seongnam-si, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • + 7 more on CT.gov