An observational study in Breast Cancer and Her 2 Positive Breast Cancer, sponsored by Société Algérienne de Formation et Recherche en Oncologie. Recruiting at 2 sites in Algeria. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Société Algérienne de Formation et Recherche en Oncologie · Observational
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Société Algérienne de Formation et Recherche en Oncologie is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult women with HER2-positive breast cancer receiving a pertuzumab biosimilar in the neoadjuvant setting or as first-line treatment in the metastatic setting.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients treated with a pertuzumab biosimilar in the neoadjuvant setting for HER2-positive breast cancer.
Patients treated with a pertuzumab biosimilar as first-line therapy in the metastatic setting for HER2-positive metastatic breast cancer.
This study also gives Pertuzumab. No intervention listed here names it: that was found by reading the record.
Treatment Regimen Utilization
Percentage (%) of patients receiving each pertuzumab biosimilar-containing treatment regimen.
Time frame: Up to 36 months
Line of Therapy
Percentage (%) of patients receiving pertuzumab biosimilar as neoadjuvant therapy or first-line treatment in metastatic setting.
Time frame: Up to 36 months
Treatment Duration
Median duration of treatment (in months) with pertuzumab biosimilar.
Time frame: Up to 36 months
Prescribing Context
Percentage (%) of prescriptions initiated in neoadjuvant versus metastatic setting.
Time frame: Up to 36 months
Methods of Response Assessment
Percentage (%) of patients assessed using clinical, radiological, and/or pathological methods.
Time frame: Up to 36 months
Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort)
Proportion of patients achieving pathological complete response (pCR) based on local histopathological assessment.
Time frame: Up to 12 months
Disease-Free Survival (DFS) (Neoadjuvant Cohort)
Time from surgery to disease recurrence or death from any cause.
Time frame: Up to 24 months
Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort)
Proportion of patients alive without disease progression at 24 months.
Time frame: 24 months
Progression-Free Survival (PFS) (Metastatic Cohort)
Time from treatment initiation to disease progression or death from any cause.
Time frame: Up to 24 months
Treatment Response (Both Cohorts)
Clinical, radiological, and/or pathological response assessed according to routine clinical practice.
Time frame: Up to 24 months
Overall Survival (OS) (Both Cohorts)
Time from treatment initiation to death from any cause.
Time frame: 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).
Time frame: Up to 24 months
Correlation Between Clinical and Biological Factors and Treatment Response
Assessment of correlation between treatment response (based on clinical, radiological, or pathological evaluation) and clinical and biological factors including age, tumor grade, hormonal receptor status, Ki-67, menopausal status, comorbidities, and treatment characteristics, using regression analysis. Results will be reported as odds ratios (OR) with 95% confidence intervals (CI).
Time frame: Up to 24 months
Plan to share: No
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Société Algérienne de Formation et Recherche en Oncologie