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
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