A Noninvasive Blood-based Combinatorial Proteomic Biomarker Assay to Detect Breast Cancer in Women Under the Age of 50 Years.

BACKGROUND: Despite significant advances in breast imaging, the ability to detect breast cancer (BC) remains a challenge. To address the unmet needs of the current BC detection paradigm, 2 prospective clinical trials were conducted to develop a blood-based combinatorial proteomic biomarker assay (Videssa Breast) to accurately detect BC and reduce false positives (FPs) from suspicious imaging findings. PATIENTS AND METHODS: Provista-001 and Provista-002 (cohort one) enrolled Breast Imaging Reporting and Data System 3 or 4 women aged under 50 years. Serum was evaluated for 11 serum protein biomarkers and 33 tumor-associated autoantibodies. Individual biomarker expression, demographics, and clinical characteristics data from Provista-001 were combined to develop a logistic regression model to detect BC. The performance was tested using Provista-002 cohort one (validation set). RESULTS: The training model had a sensitivity and specificity of 92.3% and 85.3% (BC prevalence, 7.7%), respectively. In the validation set (BC prevalence, 2.9%), the sensitivity and specificity were 66.7% and 81.5%, respectively. The negative predictive value was high in both sets (99.3% and 98.8%, respectively). Videssa Breast performance in the combined training and validation set was 99.1% negative predictive value, 87.5% sensitivity, 83.8% specificity, and 25.2% positive predictive value (BC prevalence, 5.87%). Overall, imaging resulted in 341 participants receiving follow-up procedures to detect 30 cancers (90.6% FP rate). Videssa Breast would have recommended 111 participants for follow-up, a 67% reduction in FPs (P < .00001). CONCLUSIONS: Videssa Breast can effectively detect BC when used in conjunction with imaging and can substantially reduce unnecessary medical procedures, as well as provide assurance to women that they likely do not have BC.

Review of 125 SiteSelect stereotactic large-core breast biopsy procedures.

Advances in stereotactic breast biopsies have introduced a variety of devices that yield different sizes of tissue samples. The choice of biopsy device should be based on which technique is most likely to yield a definitive diagnosis at the time of the initial biopsy. This is a prospective study of 104 patients who underwent a total of 125 stereotactic breast biopsies using the SiteSelect large-core biopsy device. From May 1999 to June 2001, 104 patients underwent 125 stereotactic breast biopsies with the SiteSelect large-core biopsy device. One hundred four 15 mm SiteSelect biopsies, eighteen 10 mm SiteSelect biopsies, and three 22 mm SiteSelect biopsies were performed. Atypical ductal hyperplasia (ADH) and ductal carcinoma in situ (DCIS) were found in 15% of the biopsies and infiltrating cancer was found in another 15% of the biopsies. Seventy-eight percent of the ADH and 90% of the DCIS lesions were associated with indeterminate calcifications noted on mammogram. Two of the 22 mm SiteSelect excisions yielded a specimen that contained the entire cancer with clear surgical margins. All of the patients with DCIS or invasive carcinoma underwent definitive surgical and adjuvant therapy. The sensitivity and specificity of SiteSelect in this series of patients was 100%. The SiteSelect biopsy procedure is safe, well tolerated by patients, and can be performed under local anesthesia. SiteSelect is comparable to an open excisional biopsy in its ability to obtain adequate tissue for accurate diagnosis, but excises significantly less normal surrounding breast tissue. Based on the data, indications for primary use of SiteSelect are indeterminate calcifications on mammogram, rebiopsy of a vacuum-assisted biopsy site that yielded atypia on pathologic examination, and complete excision of a lesion suspicious for invasive carcinoma in order to assess actual size and margin status.