Clinical trial · Observational
A Study of Trastuzumab Subcutaneous in Participants With Human Epidermal Growth Factor Receptor-2 (HER2) Positive Early Breast Cancer
Clinical Practice Surveillance of the Use of Herceptin® Subcutaneous in Patients With HER2-Positive Early Breast Cancer (HerSCin)
- 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 observational study will evaluate the efficacy, safety, tolerability and participant reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants with HER2-positive early breast cancer in routine clinical practice. Data from eligible participants will be collected for the duration of their treatment (approximately 1 year) and for 1-2 years of follow-up.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- HER2 Positive Breast Cancer Participants
- description
- Participants with HER2 positive tumors who are considered for treatment with trastuzumab SC according to the judgement of physician and according to the actual summary of product characteristics will be observed for a period of approximately 1 year and will be followed for an additional 2 years.
- interventionNames
- Drug: Trastuzumab
Primary outcomes (2)
- measure
- Percentage of Participants With Pathologic Complete Response (pCR) (For Participants Treated in Neo-Adjuvant Setting), According to Response Evaluation Criteria in Solid Tumor (RECIST), or Modified RECIST, or Cheson Criteria (As per Center Practice)
- timeFrame
- Baseline up to approximately 3 years (assessed according to routine center practice)
- measure
- Percentage of Participants Who Were Alive and Disease Free at Year 2 (For Participants Treated in the Adjuvant Setting), According to RECIST, or Modified RECIST, or Cheson Criteria (As per Center Practice)
- timeFrame
- Year 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the breast * HER2-positive tumor * Eligible for neo-adjuvant or adjuvant treatment with trastuzumab SC according to the judgement of the physician Note: As of participant recruitment (date of participant informed consent), retrospective documentation is allowed but limited to up to 9 weeks after initial start of therapy with trastuzumab SC Exclusion Criteria: * Contraindications according to the Summary of Product Characteristics of Herceptin SC * Pregnant and breastfeeding women
References
Publications (0)
Data not yet available