Clinical trial · Observational
An Observational Study of Herceptin SC Safety in Breast Cancer
Post-Marketing Surveillance of Herceptin Subcutaneous in Breast Cancer
NCT02305628CI-TRIAL-00048290completedClinicalTrials.gov clinicaltrialsProvenance
- 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 is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved local labeling. Patients will be under observation according to standard of care 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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort
- description
- Method of continuous surveillance per standard of care
Primary outcomes (1)
- measure
- Safety (composite outcome measure): Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, pregnancies, adverse drug reactions (ADRs); unexpected ADRs; expected ADRs
- timeFrame
- Up to 6 years
Secondary outcomes (2)
- measure
- Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC)
- timeFrame
- Up to 6 years
- measure
- Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- Up to 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- All patients administered Herceptin SC for the locally approved indications Exclusion Criteria: N/A
References
Publications (0)
Data not yet available
No reference posted for this study.