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
PERTUREAL
PERTUREAL
Sponsor study identifier
observational
1,000
1 country
2
Study Start
January 15, 2026
Actual (reported)Primary Completion
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2026
Actual (reported)April 2, 2026
Actual (reported)April 21, 2026
Actual (reported)January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Treatment Regimen Utilization
Percentage (%) of patients receiving each pertuzumab biosimilar-containing treatment regimen.
Up to 36 months
Line of Therapy
Percentage (%) of patients receiving pertuzumab biosimilar as neoadjuvant therapy or first-line treatment in metastatic setting.
Up to 36 months
Treatment Duration
Median duration of treatment (in months) with pertuzumab biosimilar.
Up to 36 months
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.
Adult women with HER2-positive breast cancer receiving a pertuzumab biosimilar in the neoadjuvant setting or as first-line treatment in the metastatic setting.
CAC BLIDA, Algiers, Algeria 16000
Algiers, Algeria
CHU Béni Messous, Algiers, Algeria 16000
Algiers, Algeria
First Submitted
April 2, 2026
First Posted
April 21, 2026
Study Start
January 15, 2026
Actual (reported)Primary Completion
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prescribing Context
Percentage (%) of prescriptions initiated in neoadjuvant versus metastatic setting.
Up to 36 months
Methods of Response Assessment
Percentage (%) of patients assessed using clinical, radiological, and/or pathological methods.
Up to 36 months
Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort)
Up to 12 months
Disease-Free Survival (DFS) (Neoadjuvant Cohort)
Up to 24 months
Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort)
24 months
Progression-Free Survival (PFS) (Metastatic Cohort)
Up to 24 months
Treatment Response (Both Cohorts)
Up to 24 months
Correlation Between Clinical and Biological Factors and Treatment Response
Up to 24 months
Contact the study team to confirm eligibility.
Study Completion
January 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 21, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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