Effectiveness, Safety, and Tolerability of Anti-HER2 Drugs as Targeted Therapy for Egyptian Patients With ERBB2-Positive Breast Cancer

Sponsor
Deraya University
Study ID
NCT07416409
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab (Single-Agent Anti-HER2 Therapy) — DRUG
    Monoclonal antibody directed against the HER2 receptor, received by participants as part of routine oncology care in accordance with institutional treatment guidelines for HER2-positive breast cancer. The treating physicians made treatment decisions, and no therapy was assigned or altered by the study investigators.
  • Combination Anti-HER2 Therapy (Trastuzumab + Pertuzumab or Lapatinib) — DRUG
    Dual or combined anti-HER2 targeted therapy (such as trastuzumab with pertuzumab or lapatinib) received by participants as part of routine oncology care according to institutional treatment guidelines for HER2-positive breast cancer. Treatment decisions were made by the treating physicians, and no therapy was assigned or altered by the study investigators.

Study Details

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.

Key Dates

Start date
Jun 10, 2023
Status verified
Feb 2026
Primary completion
Jun 20, 2024
Completion
Jun 20, 2025

Study Design

Enrollment
80 participants (actual)

Arms

  • Arm: Single-Agent Anti-HER2 Therapy
    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.
  • Arm: Combination Anti-HER2 Therapy
    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.

Primary Outcome Measure

Breast Cancer-Specific Mortality [ Time Frame: From baseline through 24 months of follow-up ]

Related Studies