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Chemotherapy with or without immunotherapy remains the mainstay of treatment for triple-negative breast cancer (TNBC). A subset of TNBCs express the androgen receptor (AR), representing a potential new therapeutic target. This study assessed the feasibility of adjuvant enzalutamide, an AR antagonist, in early-stage, AR-positive (AR +) TNBC.This study was a single-arm, open-label, multicenter trial in which patients with stage I-III, AR ≥ 1% TNBC who had completed standard-of-care therapy were treated with enzalutamide 160 mg/day orally for 1 year. The primary objective of this study was to evaluate the feasibility of 1 year of adjuvant enzalutamide, defined as the treatment discontinuation rate of enzalutamide due to toxicity, withdrawal of consent, or other events related to tolerability. Secondary endpoints included disease-free survival (DFS), overall survival (OS), safety, and genomic features of recurrent tumors.Fifty patients were enrolled in this study. Thirty-five patients completed 1 year of therapy, thereby meeting the prespecified trial endpoint for feasibility. Thirty-two patients elected to continue with an optional second year of treatment. Grade ≥ 3 treatment-related adverse events were uncommon. The 1-year, 2-year, and 3-year DFS were 94%, 92% , and 80%, respectively. Median OS has not been reached.This clinical trial demonstrates that adjuvant enzalutamide is a feasible and well-tolerated regimen in patients with an early-stage AR + TNBC. Randomized trials in the metastatic setting may inform patient selection through biomarker development; longer follow-up is needed to determine the effect of anti-androgens on DFS and OS in this patient population.

Background Radial sclerosing lesions (RSLs) of the breast are benign lesions that can mimic carcinoma on mammography and are frequently associated with malignancy. Guidelines for the selection of patients with RSL on core needle biopsy who require surgical excision are not well defined. We describe the clinical management of RSL diagnosed using a percutaneous vacuum-assisted 9- or 11-gauge stereotactically guided core needle biopsy (SCNB) device. Methods We retrospectively evaluated data on patients with mammographically detected RSLs sampled by SCNB between 2001 and 2007. Demographic data, the size and type of lesion and histological findings were correlated with subsequent surgical excision data. Clinical and radiological follow-up data were collected. Results Among 80 patients with RSLs, 19 underwent surgical excision, and 61 had mammographic surveillance only. RSLs associated on imaging with an underlying architectural distortion were more frequently excised than those associated with calcifications (P = 0.003). The presence of residual calcifications/architectural distortion on post-biopsy mammogram significantly correlated with subsequent excision (P = 0.00003). Proliferative and/or atypical RSLs were more often excised than nonproliferative RSLs (P = 0.00001). In two patients, proliferative RSL was upgraded to atypical RSL on excision. Clinical and mammographic follow-up for a mean of 32 months (standard deviation, ±23) in the group without excision showed no cancer. Conclusions Architectural distortion on imaging, residual abnormality on post-biopsy mammogram and the presence of proliferative changes and/or epithelial atypia on SCNB were parameters leading to increased performance of surgical excision in our series. No diagnoses were upgraded to malignancy after excision of RSLs, suggesting that more extensive sampling by a 9- or 11-gauge SCNB device, followed by meticulous correlation of radiological and pathological findings and close clinical/radiological follow-up, could obviate surgical excision in the majority of RSL cases without associated atypia on SCNB.

Dynamic contrast-enhanced breast magnetic resonance (MR) is a promising emerging technique for evaluating breast lesions. A quantitative systematic review was performed to estimate the accuracy of breast MR in the diagnosis of high-risk breast lesions and breast cancer. A comprehensive search of the Cochrane Library, MEDLINE, CANCERLIT, LILACS, and EMBASE databases was performed from January 1985 to August 2010. The medical subjects heading (MeSH) and text words for the terms “breast neoplasm”, “breast lesions”, “breast cancer” and “magnetic resonance” were combined with the MeSH term diagnosis (“sensitivity and specificity”). Studies that compared breast MR with paraffin-embedded sections parameters for the diagnosis of breast lesions (benign, high-risk borderline, and breast cancer) were included. Sixty-nine studies were analyzed, which included 9,298 women with 9,884 breast lesions. Interrater overall agreement between breast MR and paraffin section diagnosis was 79% (κ = 0.55), indicating moderate agreement. Pooled sensitivity and specificity were 90% [95% CI 88–92%] and 75% [95% CI 70–79%], respectively. The pooled likelihood positive ratio was 3.64 (95% CI 3.0–4.2) and the negative ratio was 0.12 (95% CI 0.09–0.15). For breast cancer or high-risk lesions versus benign lesions, the AUC was 0.91 for breast MR and the point Q* was 0.84. In summary, breast MR is a useful pre-operative test for predicting the diagnosis of breast lesions.