Breast Neoplasms, HER2-positive Breast Cancer, Metastatic Breast Cancer, Oncology
Conditions
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.
Interventions
DRUGTrastuzumab (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.
DRUGCombination 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.
Sponsors
Deraya University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast Cancer-Specific Mortality | 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. |
| Progression-Free Survival (PFS) | Baseline to 24 months | Time from initiation of Anti-HER2 therapy to disease progression or death, confirmed radiologically or clinically. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiologically Evident Recurrence or Metastases | Baseline to 24 months | Recurrence or metastasis detected through periodic imaging (mammography, CT, ultrasound, or bone scan). |
| Tumor Markers (CEA, CA15-3) | Baseline, every 6 months, and at study compeletion | Change in serum levels of carcinoembryonic antigen (CEA) and cancer antigen (CA15-3) to monitor disease progression. |
| Adverse Drug Reactions | Throughout 24-month follow-up period | Frequency and severity of adverse events (e.g., cardiotoxicity, gastrointestinal toxicity, fatigue) graded by NCI-CTCAE v4.0. |
Countries
Egypt
Outcome results
None listed