NCT04118192

NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer

Can Patients With Residual Cancer After Chemotherapy for Early Breast Cancer be Identified With Multiple Ultrasound-guided Biopsies?

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: University of Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective non-randomised multi-centre feasibility study to assess if patients with residual cancer following dual-targeted neoadjuvant chemotherapy treatment for HER2-positive, ER-negative early breast cancer can be identified by multiple ultrasound (US)-guided tumour bed core biopsies

Detailed description

The NOSTRA-Feasibility study is designed to determine if it is safe to omit surgery after the planned neoadjuvant chemotherapy plus dual-targeted anti-HER2 treatment. The study is needed to determine whether patients with residual cancer can be identified by histological examination of multiple ultrasound-guided tumour bed core biopsies following dual-targeted neoadjuvant treatment for HER2-positive, ER-negative early primary breast cancer and whether there is concordance between local pathology reporting and central pathology reporting by the trials expert pathologists.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Tumour bed core biopsy	Collection of up to 8 core biopsies across 4 zones of the whole tumour bed to detect residual cancer post neo-adjuvant treatment

Timeline

• Start date: 2019-05-22
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-10-08
• Last updated: 2025-01-24

Locations

24 sites across 1 country: United Kingdom