Neoadjuvant systemic chemotherapy (NST) is increasingly recommended for patients with early breast cancer, and the rate of cases with complete pathological remission (pCR) is on the rise due to the use of modern chemotherapy regimens and targeted therapies, especially in patients with human epidermal growth factor receptor 2 positive (HER2+) and triple-negative breast cancer (TNBC). It is, therefore, important to mark a lesion before the start of NST to ensure safe localization of the clip after completion of NST. In case of pCR, localization of the clip is often performed under mammographic control. Reliable sonographic detection and marking of the clip would be preferred, since a mammography implies additional radiation exposure and increased personnel, time, and financial expenditures. The present study aims to evaluate the sonographic detection rate (DR) of the intramammary Tumark® Vision clip after NST.
The Ultra3Detect study (ClinicalTrials.gov ID: NCT04468113) is a multicenter, prospective, investigator initiated registry study. The study includes women aged ≥ 18 years with early breast cancer (cM0) and an indication for breast-conserving therapy and NST. Patients who are scheduled for marking of the lesion with the Tumark® Vision Clip (SOMATEX® Medical Technologies, Berlin, Germany) are eligible. Women with prior extensive breast surgery or those already undergoing adjuvant or neoadjuvant chemotherapy are excluded from the investigation. If the clip can be detected preoperatively by ultrasound, then ultrasound-guided wire marking is performed, otherwise stereotactic marking is required. The primary endpoint is the sonographic DR of Tumark® Vision clips at the time of surgery after completion of NST treatment of at least 12 weeks in patients with HER2+ and TNBC. Main secondary endpoints are the sonographic DRs during NST treatment at different time points (4–8, 9–12, ≥ 13 weeks), the intraoperative DR of the clip, and the proportion of cases in which mammography-guided wire marking can be avoided. Since the start of enrollment in May 2020, 104 patients (30% of target cohort) have been registered in 18 study centers.
Clinical trial identification
Legal entity responsible for the study
Breast Unit, Kliniken Essen-Mitte.
Has not received any funding.
S. Kümmel: Financial Interests, Personal, Advisory Board: Lilly, Roche, Genomic Health, Novartis, Amgen, Celgene, Daiichi Sankyo, AstraZeneca, Somatex, MSD, Pfizer, PFM medical, Seagen; Financial Interests, Personal, Principal Investigator: Novartis, Somatex, Roche; Non-Financial Interests, Personal, Other, travel expenses: Roche, Daiichi Sankyo, Sonoscape. E. Breit: Financial Interests, Personal, Writing Engagements: Sysmex, Olympus, Merck Serono, Daiichi Sankyo. S. Hentsch: Financial Interests, Personal, Writing Engagements: Aesculap. A. Rüland: Financial Interests, Personal, Invited Speaker: Roche, Pfizer; Non-Financial Interests, Personal, Other, Travel expenses: Celgene. P. Dall: Financial Interests, Personal, Advisory Board: Roche, Novartis, Eisai, Hexal, Tesaro, Pierre Fabre, Amgen, Clovis, Olympus; Non-Financial Interests, Personal, Other, travel expenses: Clovis, Pierre Fabre, Olympus, Roche, Novartis, Tesaro, Hexal. M. Reinisch: Financial Interests, Personal, Advisory Board: Lilly, Roche, Novartis, Daiichi Sankyo, AstraZeneca, MSD, Pfizer, Seagen; Non-Financial Interests, Personal, Other, Travel expenses: Novartis, Celgene, Pfizer; Financial Interests, Personal, Invited Speaker: Somatex. All other authors have declared no conflicts of interest.