Observational Study of Pertuzumab Safety in Participants With Breast Cancer

  • Cancer
  • Breast Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Cities
  • Anyang
  • Bucheon
  • Busan
  • Daegu
  • Daejeon
  • Goyang-si
  • Hwasun
  • Iksan
  • Incheon
  • Seongnam-si
  • Seoul
  • Suwon
  • Ulsan
  • Yangsan
Trial Identifier:

NCT02266173 ML29299

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT02266173, ML29299 Trial Identifier
      Pertuzumab Treatments
      Breast Cancer Condition
      Official Title

      Post-Marketing Surveillance of Perjeta in Breast Cancer

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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