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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Metastatic Breast Cancer; HER2-positive Breast Cancer; Oncology
• Intervention / Treatment: Drug: Trastuzumab (Single-Agent Anti-HER2 Therapy); Drug: Combination Anti-HER2 Therapy (Trastuzumab + Pertuzumab or Lapatinib)

Detailed Description

This study was designed as a prospective observational cohort study conducted in routine clinical practice settings. A total of 80 adult Egyptian females with pathologically confirmed human epidermal growth factor receptor 2 (HER2)-positive breast cancer were enrolled and followed over time. Participants received anti-HER2 therapies as part of standard oncology care determined by their treating physicians. No treatment was assigned, administered, or modified by the investigators for this study.

Patients were categorized into cohorts based on the therapy they were already receiving, including single-agent anti-HER2 therapy (for example, trastuzumab) or combination anti-HER2 therapy (for example, trastuzumab with pertuzumab or lapatinib).

Baseline assessments included physical examination, mammography, breast ultrasonography, and laboratory investigations as part of routine clinical evaluation. Participants were followed prospectively with clinical examinations every two months and radiological assessments every four to six months (sonomammogram, computed tomography (CT), or bone scan) according to institutional protocols.

Outcome measures included treatment response, progression-free survival (defined as the time from initiation of therapy to documented disease progression or death), recurrence, and adverse events. Adverse effects were documented and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0. Statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS), version 22, to compare outcomes between treatment cohorts and to identify predictors of tolerability and survival.

This study does not involve experimental intervention, randomisation, or alteration of therapeutic regimens, but rather evaluates real-world outcomes associated with anti-HER2 therapies in an Egyptian population.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Egypt
  • Menia Governorate
    • Cairo, Menia Governorate, Egypt
      • Dar Al-Salam Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult female Egyptian patients aged 18-65 years with HER2-positive breast cancer recruited from Dar Al-Salam Oncology Hospital (Cairo) and El-Hussein Hospital (Faculty of Medicine, Al-Azhar University), treated according to institutional oncology protocols.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Trastuzumab (Single-Agent Anti-HER2 Therapy); 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; 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.	Drug: Combination Anti-HER2 Therapy (Trastuzumab + Pertuzumab or Lapatinib); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast Cancer-Specific Mortality	Number of deaths attributable to breast cancer will be recorded to assess survival outcomes among treatment groups.	From baseline through 24 months of follow-up
Progression-Free Survival (PFS)	Time from initiation of Anti-HER2 therapy to disease progression or death, confirmed radiologically or clinically.	Baseline to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiologically Evident Recurrence or Metastases	Recurrence or metastasis detected through periodic imaging (mammography, CT, ultrasound, or bone scan).	Baseline to 24 months
Tumor Markers (CEA, CA15-3)	Change in serum levels of carcinoembryonic antigen (CEA) and cancer antigen (CA15-3) to monitor disease progression.	Baseline, every 6 months, and at study compeletion
Adverse Drug Reactions	Frequency and severity of adverse events (e.g., cardiotoxicity, gastrointestinal toxicity, fatigue) graded by NCI-CTCAE v4.0.	Throughout 24-month follow-up period

Collaborators and Investigators

• Sponsor: Deraya University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 15, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Neoplasms; Breast Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Quinazolines; Trastuzumab; Lapatinib; pertuzumab
• Other Study ID Numbers: DU-CP-HER2-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No