Effectiveness, Safety, and Tolerability of Anti-HER2 Drugs as Targeted Therapy for Egyptian Patients With ERBB2-Positive Breast Cancer
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Menia Governorate
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Cairo, Menia Governorate, Egypt
- Dar Al-Salam Cancer Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
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.
|
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.
|
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
Time Frame: From baseline through 24 months of follow-up
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Number of deaths attributable to breast cancer will be recorded to assess survival outcomes among treatment groups.
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From baseline through 24 months of follow-up
|
|
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.
|
Baseline to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiologically Evident Recurrence or Metastases
Time Frame: Baseline to 24 months
|
Recurrence or metastasis detected through periodic imaging (mammography, CT, ultrasound, or bone scan).
|
Baseline to 24 months
|
|
Tumor Markers (CEA, CA15-3)
Time Frame: 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.
|
Baseline, every 6 months, and at study compeletion
|
|
Adverse Drug Reactions
Time Frame: Throughout 24-month follow-up period
|
Frequency and severity of adverse events (e.g., cardiotoxicity, gastrointestinal toxicity, fatigue) graded by NCI-CTCAE v4.0.
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Throughout 24-month follow-up period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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