Abstract GS5-06: Towards omitting breast surgery in patients with a pathologic complete response after neoadjuvant systemic treatment: interim analysis of the MICRA trial (Minimally Invasive Complete Response Assessment)
Authors: Peeters Marie-Jeanne T.F.D. Vrancken , van Loevezijn A , van der Noordaa M EM , van Duijnhoven F H , Loo C E , van Werkhoven E , van de Vijver K K , Wiersma T , Winter-Warnars H AO , Sonke G S , Blanken C. , Zonnevels B. 
Published: March 2020

Background and Objectives: Improvements in neoadjuvant systemic therapy (NST) for breast cancer patients have led to increasing rates of pathologic complete response (pCR). In patients with an excellent response, imaging alone is not reliable enough to differentiate between patients with residual disease, who should be surgically treated or patients with pCR where surgery could be considered overtreatment. Several trials currently investigate the accuracy of minimal invasive biopsies to assess presence of pCR of the breast. We initiated the MICRA trial (Minimal Invasive Complete Response Assessment NTR6120) combining MRI and minimal invasive biopsies of the breast.

Methods: Breast cancer patients treated with NST resulting in a radiologic complete (rCR) or partial response (rPR, &gt; 30 % decrease and &lt; 2 cm residual diameter) on MRI are eligible. Post-NST, eight ultrasound-guided 14G core biopsies of the pre-NST marked tumor area are obtained. Pathology results of biopsies and surgical specimens are compared. The primary endpoint is the false-negative rate (FNR) of the biopsy procedure i.e. the proportion of patients with non-pCR in the surgical specimen but with pCR in the biopsies. Here we report results of the interim analysis.

Results: 219 patients were enrolled in the trial. Biopsies were successfully obtained and analyzed in 167 patients. Main age was 49 yrs (range 24-74). Tumor subtype was 26% hormone receptor positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-), 14% HR-/HER2+, 36% triple negative and 24% HR+HER2+. 135 patients had a rCR and 32 patients a rPR on MRI. There were 89 patients (53%) with pCR in the surgical specimen, all correctly identified by post-NST biopsies (false-positive rate 0%). Post-NST biopsies however missed residual disease in 29/78 patients (FNR 37%). FNR was higher in patients with rCR (FNR 45%; 26/55 patients with residual disease missed on biopsies) than in patients with rPR (FNR 13 %; 3/23 patients with residual disease missed with biopsies). The conditional power estimating the probability of the FNR being ≤ 8% at final analysis was &lt; 1%.

MICRA patients total n=167Specimen negSpecimen posBiopsy neg8929118FNR= 29/7837%Biopsy pos049498978167

Conclusions: Ultrasound-guided core biopsies of the breast in patients with excellent response on MRI after NST are not accurate enough to safely select patients with pCR for omission of surgery.

Citation Format: Marie-Jeanne T.F.D. Vrancken Peeters, A van Loevezijn, M EM van der Noordaa, F H van Duijnhoven, C E Loo, E van Werkhoven, K K van de Vijver, T Wiersma, H AO Winter-Warnars, G S Sonke, C. Blanken, B. Zonnevels. Towards omitting breast surgery in patients with a pathologic complete response after neoadjuvant systemic treatment: interim analysis of the MICRA trial (Minimally Invasive Complete Response Assessment) [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr GS5-06.