Real-World Cohort Study Comparing Adjuvant HP vs T-DM1 in HER2+ Breast Cancer Non-pCR Patients
Summary
NIH's ClinicalTrials.gov registered a multicenter, retrospective, real-world cohort study (NCT07540520) comparing two adjuvant treatment regimens for HER2-positive breast cancer patients with non-pCR after neoadjuvant therapy: trastuzumab combined with pertuzumab (HP group) versus ado-trastuzumab emtansine (T-DM1 group). The study will analyze data from patients treated between July 2019 and July 2025 with a planned enrollment of 2,000 cases.
What changed
NIH registered a new observational study on ClinicalTrials.gov. The study retrospectively examines outcomes for HER2-positive breast cancer patients who did not achieve pathological complete response (non-pCR) after neoadjuvant therapy, comparing those who received adjuvant trastuzumab plus pertuzumab versus T-DM1. Data collection spans July 2019 to July 2025.
This study registration applies to clinical investigators, healthcare providers, and pharmaceutical companies whose HER2-targeted therapies are under evaluation. Sponsors conducting similar real-world evidence studies in oncology may find this registry entry relevant for identifying peer research methodologies and competitive landscape awareness.
Archived snapshot
Apr 20, 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.
A Real-World Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy
Observational NCT07540520 Kind: OBSERVATIONAL Apr 20, 2026
Abstract
This study is a multicenter, retrospective, real-world cohort study. It retrospectively collected data from HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab-containing chemotherapy regimens and had Non-pCR after surgery between July 2019 and July 2025. Patients were divided into two groups based on their adjuvant treatment regimens: the trastuzumab combined with pertuzumab group (HP) and the ado-trastuzumab emtansine group (T-DM1). The planned sample size is 2000 cases.
Conditions: Early Breast Cancer
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