Clinical trial · Observational
Observational Study of Pertuzumab Safety in Participants With Breast Cancer
Post-Marketing Surveillance of Perjeta in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pertuzumab | Drug | Pertuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Pertuzumab
Primary outcomes (1)
- measure
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- Baseline up to approximately 6 years
Secondary outcomes (1)
- measure
- Percentage of Participants With Overall Response as Determined Using Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- Baseline until disease progression or death, whichever occurs earlier (assessed up to approximately 6 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available