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
Summary
NIH's ClinicalTrials.gov has registered a new observational study (NCT07542496) evaluating real-world utilization patterns and clinical outcomes of a pertuzumab biosimilar in patients with breast cancer across neoadjuvant and first-line metastatic settings. The study will assess pathological complete response, disease-free survival, progression-free survival, overall survival, treatment response, and safety. This study registration applies to clinical investigators and healthcare providers involved in breast cancer treatment and biosimilar research.
What changed
NIH's ClinicalTrials.gov has registered a new bicohort observational study examining real-world utilization and clinical outcomes of a pertuzumab biosimilar in treating breast cancer. The study covers two patient cohorts: neoadjuvant and first-line metastatic disease settings. Researchers will evaluate pathological complete response, disease-free survival, progression-free survival, overall survival, treatment response, and adverse events per CTCAE criteria.
Clinical investigators and healthcare providers conducting breast cancer research should note this study for awareness. Pharmaceutical companies developing or marketing pertuzumab biosimilars may find the real-world effectiveness data relevant to their products. Patients and patient advocacy groups may find this study of interest for understanding current biosimilar research directions.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
Observational NCT07542496 Kind: OBSERVATIONAL Apr 21, 2026
Abstract
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.
Conditions: Breast Cancer, Her 2 Positive Breast Cancer
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