Clinical trial · Observational
Effectiveness, Safety, and Tolerability of Anti-HER2 Drugs as Targeted Therapy for Egyptian Patients With ERBB2-Positive 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)
Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is an aggressive subtype characterized by overexpression of the HER2 receptor. Anti-HER2 therapies such as trastuzumab and pertuzumab are widely used in clinical practice and have improved patient outcomes; however, their effectiveness and safety profiles may vary across populations. This prospective observational cohort study evaluates the real-world effectiveness, safety, and tolerability of single-agent versus combination anti-HER2 therapy among Egyptian patients with erb-b2 receptor tyrosine kinase 2 (ERBB2)-positive breast cancer. The study aims to describe treatment outcomes and identify factors associated with survival and tolerability in routine clinical practice.
Conditions
Conditions (4)
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 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination Anti-HER2 Therapy (Trastuzumab + Pertuzumab or Lapatinib) | Drug | — | UNRESOLVED |
| Trastuzumab (Single-Agent Anti-HER2 Therapy) | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Single-Agent Anti-HER2 Therapy
- description
- Patients receiving single-agent human epidermal growth factor receptor 2 (HER2)-targeted therapy, such as trastuzumab, as part of routine standard-of-care treatment for HER2-positive breast cancer. Treatment decisions were made by the treating oncologists according to institutional protocols. Participants were observed prospectively and followed for treatment response, disease progression, and adverse effects.
- interventionNames
- Drug: Trastuzumab (Single-Agent Anti-HER2 Therapy)
- label
- Combination Anti-HER2 Therapy
- description
- Patients receiving combination human epidermal growth factor receptor 2 (HER2)-targeted therapy, such as trastuzumab with pertuzumab or lapatinib, as part of routine standard-of-care management according to institutional oncology protocols. Treatment decisions were made by the treating oncologists, and no therapy was assigned or modified by the study investigators. Participants were observed prospectively and followed for treatment response, disease progression, and adverse effects.
- interventionNames
- Drug: Combination Anti-HER2 Therapy (Trastuzumab + Pertuzumab or Lapatinib)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed ERBB2-positive breast cancer * Female, aged 18-65 years * Performance status 0-2 (WHO criteria) * Adequate cardiac, hepatic, and renal function * No prior chemotherapy or radiotherapy for breast cancer Exclusion Criteria: * Pregnancy or lactation * Age \<18 or \>65 years * Prior treatment for breast cancer * Metastatic disease at initial diagnosis * Left ventricular ejection fraction below normal limit * Severe comorbidities preventing safe Anti-HER2 therapy
References
Publications (0)
Data not yet available