Breast CancerPERTUREALNCT07542496
Real-world Bicohort Observational Study of a Pertuzumab Biosimilar in the Treatment of Breast Cancer: in the Neoadjuvant Setting and in First-line Metastatic Disease
An observational study of Breast Cancer and Her 2 Positive Breast Cancer, run by Société Algérienne de Formation et Recherche en Oncologie at 2 sites in Algeria.
Trial summary
The goal of this observational study is to describe the real-world utilization patterns of a pertuzumab biosimilar and to evaluate its clinical outcomes in patients with breast cancer in both neoadjuvant and metastatic settings. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer, Her 2 Positive Breast Cancer
- How many people
- 1,000 participants
- Where
- 2 sitesAlgeria
- Study dates
- 15 Jan 2026to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women with HER2-positive breast cancer receiving a pertuzumab biosimilar in the neoadjuvant setting or as first-line treatment in the metastatic setting.
Who may be able to join
- Age ≥ 19 years at the time of inclusion;
- Histologically confirmed diagnosis of HER2-positive invasive breast cancer (IHC 3+ score or HER2 amplification by FISH/CISH/SISH);
- Decision to initiate treatment with a pertuzumab biosimilar in the neoadjuvant setting (neoadjuvant cohort) or as first-line therapy in the metastatic setting (metastatic cohort), in accordance with local indications;
- Treatment prescribed as part of routine clinical care (outside of a clinical trial);
- Patient informed and having provided written informed consent.
Who cannot join
- Treatment with pertuzumab in a therapeutic setting other than neoadjuvant or first-line metastatic (e.g., adjuvant, late recurrence beyond first-line, maintenance therapy alone, etc.);
- Treatment administered as part of an interventional clinical trial;
- History of severe allergy or known contraindication to pertuzumab;
- Medical records unavailable or inability to ensure at least 6 months of minimal follow-up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Algeria2 sites, 2 recruiting
- Recruiting
CAC BLIDA, Algiers, Algeria 16000
Algiers
BOUNEDJAR Adda, Professor, +213 25 20 90 72, contact@esclinicalresearch.com
- Recruiting
CHU Béni Messous, Algiers, Algeria 16000
Algiers
Oukkal Mohammed, Professor, +213 219 311 90, contact@esclinicalresearch.com
About this study
The goal of this observational study is to describe the real-world utilization patterns of a pertuzumab biosimilar and to evaluate its clinical outcomes in patients with breast cancer in both neoadjuvant and metastatic settings. It also aims to assess pathological complete response (pCR), disease-free survival (DFS) in the neoadjuvant cohort, progression-free survival (PFS) in the metastatic cohort, overall survival (OS), treatment response, and safety and tolerability (adverse events according to CTCAE) across both cohorts.
Read the detailed description
This is a non-interventional, prospective, multicenter, bicohort observational study conducted in a real-world setting. It aims to describe the clinical and therapeutic characteristics of patients treated with a pertuzumab biosimilar and to evaluate outcomes in both neoadjuvant and metastatic settings. Approximately 1,000 patients will be included, with 500 patients per cohort. Cohort 1 includes patients receiving a pertuzumab biosimilar in the neoadjuvant treatment of HER2-positive breast cancer, while Cohort 2 includes patients treated in the first-line metastatic setting for HER2-positive metastatic breast cancer.
- Conditions
- Breast Cancer, Her 2 Positive Breast Cancer
- Keywords
- Algerian Study, Real-world data, Algeria, Biosimilar, Pertuzumab, Breast Cancer, Cancer, Breast cancer in Algerian patients, HER2-Positive Breast Cancer, Neoadjuvant Therapy, Anti-HER2 Therapy, Cohort Study, Non-Interventional Study, HER2-Targeted Therapy, Observational Study
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients treated with a pertuzumab biosimilar in the neoadjuvant setting for HER2-positive breast cancer. | |
| Cohort 2 | Patients treated with a pertuzumab biosimilar as first-line therapy in the metastatic setting for HER2-positive metastatic breast cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Regimen Utilization
Percentage (%) of patients receiving each pertuzumab biosimilar-containing treatment regimen.
Measured: Up to 36 months
Line of Therapy
Percentage (%) of patients receiving pertuzumab biosimilar as neoadjuvant therapy or first-line treatment in metastatic setting.
Measured: Up to 36 months
Treatment Duration
Median duration of treatment (in months) with pertuzumab biosimilar.
Measured: Up to 36 months
Prescribing Context
Percentage (%) of prescriptions initiated in neoadjuvant versus metastatic setting.
Measured: Up to 36 months
Methods of Response Assessment
Percentage (%) of patients assessed using clinical, radiological, and/or pathological methods.
Measured: Up to 36 months
Secondary outcomes (7)
Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort)
Proportion of patients achieving pathological complete response (pCR) based on local histopathological assessment.
Measured: Up to 12 months
Disease-Free Survival (DFS) (Neoadjuvant Cohort)
Time from surgery to disease recurrence or death from any cause.
Measured: Up to 24 months
Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort)
Proportion of patients alive without disease progression at 24 months.
Measured: 24 months
Progression-Free Survival (PFS) (Metastatic Cohort)
Time from treatment initiation to disease progression or death from any cause.
Measured: Up to 24 months
Treatment Response (Both Cohorts)
Clinical, radiological, and/or pathological response assessed according to routine clinical practice.
Measured: Up to 24 months
Overall Survival (OS) (Both Cohorts)
Time from treatment initiation to death from any cause.
Measured: Up to 24 months
Incidence and Severity of Adverse Events
Incidence (%) and severity of adverse events (AEs), graded according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Jan 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société Algérienne de Formation et Recherche en Oncologie
- Sponsor type
- University, hospital or other
- Collaborators
- ES Clinical Research, AlgenPharm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542496
- Sponsor's protocol ID
- SAFRO 0304
- Acronym
- PERTUREAL
- Status last verified
- Jan 2026
- First submitted
- 2 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Bicohort Observational Study of a Pertuzumab Biosimilar in the Treatment of Breast Cancer: in the Neoadjuvant Setting and in First-line Metastatic Disease
- ClinicalTrials.gov ID
- NCT07542496
- Acronym / sponsor ID
- PERTUREAL / SAFRO 0304
- Conditions
- Breast Cancer, Her 2 Positive Breast Cancer
- Keywords
- Algerian Study, Real-world data, Algeria, Biosimilar, Pertuzumab, Breast Cancer, Cancer, Breast cancer in Algerian patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Société Algérienne de Formation et Recherche en OncologieUniversity, hospital or other
- Collaborators
- ES Clinical Research, AlgenPharm
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 21 Apr 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.
The goal of this observational study is to describe the real-world utilization patterns of a pertuzumab biosimilar and to evaluate its clinical outcomes in patients with breast cancer in both neoadjuvant and metastatic settings. It also aims to assess pathological complete response (pCR), disease-free survival (DFS) in the neoadjuvant cohort, progression-free survival (PFS) in the metastatic cohort, overall survival (OS), treatment response, and safety and tolerability (adverse events according to CTCAE) across both cohorts.
Detailed description
This is a non-interventional, prospective, multicenter, bicohort observational study conducted in a real-world setting. It aims to describe the clinical and therapeutic characteristics of patients treated with a pertuzumab biosimilar and to evaluate outcomes in both neoadjuvant and metastatic settings. Approximately 1,000 patients will be included, with 500 patients per cohort. Cohort 1 includes patients receiving a pertuzumab biosimilar in the neoadjuvant treatment of HER2-positive breast cancer, while Cohort 2 includes patients treated in the first-line metastatic setting for HER2-positive metastatic breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients treated with a pertuzumab biosimilar in the neoadjuvant setting for HER2-positive breast cancer. |
| Cohort 2 | – | –Patients treated with a pertuzumab biosimilar as first-line therapy in the metastatic setting for HER2-positive metastatic breast cancer. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women with HER2-positive breast cancer receiving a pertuzumab biosimilar in the neoadjuvant setting or as first-line treatment in the metastatic setting.
Key inclusion criteria (5 listed)
- Age ≥ 19 years at the time of inclusion;
- Histologically confirmed diagnosis of HER2-positive invasive breast cancer (IHC 3+ score or HER2 amplification by FISH/CISH/SISH);
- Decision to initiate treatment with a pertuzumab biosimilar in the neoadjuvant setting (neoadjuvant cohort) or as first-line therapy in the metastatic setting (metastatic cohort), in accordance with local indications;
- Treatment prescribed as part of routine clinical care (outside of a clinical trial);
- Patient informed and having provided written informed consent.
Key exclusion criteria (4 listed)
- Treatment with pertuzumab in a therapeutic setting other than neoadjuvant or first-line metastatic (e.g., adjuvant, late recurrence beyond first-line, maintenance therapy alone, etc.);
- Treatment administered as part of an interventional clinical trial;
- History of severe allergy or known contraindication to pertuzumab;
- Medical records unavailable or inability to ensure at least 6 months of minimal follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Regimen Utilization
Time frame: Up to 36 months
Percentage (%) of patients receiving each pertuzumab biosimilar-containing treatment regimen.
Line of Therapy
Time frame: Up to 36 months
Percentage (%) of patients receiving pertuzumab biosimilar as neoadjuvant therapy or first-line treatment in metastatic setting.
Treatment Duration
Time frame: Up to 36 months
Median duration of treatment (in months) with pertuzumab biosimilar.
Prescribing Context
Time frame: Up to 36 months
Percentage (%) of prescriptions initiated in neoadjuvant versus metastatic setting.
Methods of Response Assessment
Time frame: Up to 36 months
Percentage (%) of patients assessed using clinical, radiological, and/or pathological methods.
7 secondary outcomes
Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort)
Time frame: Up to 12 months
Disease-Free Survival (DFS) (Neoadjuvant Cohort)
Time frame: Up to 24 months
Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort)
Time frame: 24 months
Progression-Free Survival (PFS) (Metastatic Cohort)
Time frame: Up to 24 months
Treatment Response (Both Cohorts)
Time frame: Up to 24 months
Overall Survival (OS) (Both Cohorts)
Time frame: Up to 24 months
Incidence and Severity of Adverse Events
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 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.
CHU Béni Messous, Algiers, Algeria 16000
Algiers, Algeria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Her 2 Positive Breast Cancer, run by Société Algérienne de Formation et Recherche en Oncologie at 2 sites in Algeria.
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 4 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Algeria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Regimen Utilization (time frame: Up to 36 months). The study lists 5 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 21 Apr 2026.