Changeflow GovPing Healthcare & Life Sciences Real-world Bicohort Observational Study of a Pe...
Routine Notice Added Final

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

Favicon for changeflow.com ClinicalTrials.gov Studies
Published
Detected
Email

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.

Published by NIH on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

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, 2026

GovPing 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.

← ClinicalTrials.gov Studies

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

View original document →

Get daily alerts for ClinicalTrials.gov Studies

Daily digest delivered to your inbox.

Free. Unsubscribe anytime.

About this page

What is GovPing?

Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission

What's from the agency?

Source document text, dates, docket IDs, and authority are extracted directly from NIH.

What's AI-generated?

The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.

Last updated

Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07542496

Who this affects

Applies to
Clinical investigators Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical research Drug evaluation Treatment outcomes
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Pharmaceuticals Public Health

Get alerts for this source

We'll email you when ClinicalTrials.gov Studies publishes new changes.

Free. Unsubscribe anytime.

You're subscribed!