Effectiveness, Safety, and Tolerability of Anti-HER2 Drugs as Targeted Therapy for Egyptian Patients With ERBB2-Positive Breast Cancer
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Deraya University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS)
Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Trastuzumab (Single-Agent Anti-HER2 Therapy) (Drug)
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.
Intervention: Combination Anti-HER2 Therapy (Trastuzumab + Pertuzumab or Lapatinib) (Drug)
Outcomes
Primary Outcomes
Progression-Free Survival (PFS)
Time Frame: Baseline to 24 months
Time from initiation of Anti-HER2 therapy to disease progression or death, confirmed radiologically or clinically.
Breast Cancer-Specific Mortality
Time Frame: From baseline through 24 months of follow-up
Number of deaths attributable to breast cancer will be recorded to assess survival outcomes among treatment groups.
Secondary Outcomes
- 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)