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

NCT07416409 | Completed

• 1 other identifier: DU-CP-HER2-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Neoplasms; Oncology; HER2-positive Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Radiologically Evident Recurrence or Metastases

  Baseline to 24 months

• Tumor Markers (CEA, CA15-3)

  Baseline, every 6 months, and at study compeletion

• Adverse Drug Reactions

  Throughout 24-month follow-up period

Study Arms (2)

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)

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)

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.

Single-Agent Anti-HER2 Therapy

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.

Combination Anti-HER2 Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Dar Al-Salam Cancer Hospital

Cairo, Menia Governorate, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Trastuzumab; pertuzumab; Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 18, 2026
• Study Start: June 10, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)