Breast NeoplasmsNCT07416409
Effectiveness, Safety, and Tolerability of Anti-HER2 Drugs as Targeted Therapy for Egyptian Patients With ERBB2-Positive Breast Cancer
An observational study of Breast Neoplasms and Oncology, run by Deraya University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Neoplasms, Oncology, HER2-positive Breast Cancer
- What is being tested?
- Trastuzumab (Single-Agent Anti-HER2 Therapy) and Combination Anti-HER2 Therapy (Trastuzumab + Pertuzumab or Lapatinib)
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2023to 20 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Trastuzumab (Single-Agent Anti-HER2 Therapy), Combination Anti-HER2 Therapy (Trastuzumab + Pertuzumab or Lapatinib)
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Combination Anti-HER2 Therapy (Trastuzumab + Pertuzumab or Lapatinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer-Specific Mortality
Number of deaths attributable to breast cancer will be recorded to assess survival outcomes among treatment groups.
Measured: 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.
Measured: Baseline to 24 months
Secondary outcomes (3)
Radiologically Evident Recurrence or Metastases
Recurrence or metastasis detected through periodic imaging (mammography, CT, ultrasound, or bone scan).
Measured: 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.
Measured: 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.
Measured: Throughout 24-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start10 Jun 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416409
- Sponsor's protocol ID
- DU-CP-HER2-001
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Safety, and Tolerability of Anti-HER2 Drugs as Targeted Therapy for Egyptian Patients With ERBB2-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07416409
- Acronym / sponsor ID
- DU-CP-HER2-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Agent Anti-HER2 Therapy | – | Drug: Trastuzumab (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. |
| Combination Anti-HER2 Therapy | – | Drug: Combination Anti-HER2 Therapy (Trastuzumab + Pertuzumab or Lapatinib)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Single-Agent Anti-HER2 Therapy |
| 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. | Drug | Combination Anti-HER2 Therapy |
Primary outcome
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.
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.
3 secondary outcomes
Radiologically Evident Recurrence or Metastases
Time frame: Baseline to 24 months
Tumor Markers (CEA, CA15-3)
Time frame: Baseline, every 6 months, and at study compeletion
Adverse Drug Reactions
Time frame: Throughout 24-month follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Oncology, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cancer-Specific Mortality (time frame: From baseline through 24 months of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.