Breast Cancer Study of Tumor Markers

Study participants were women with breast cancer recruited between 2001 and 2015 for the WCHS, a multisite case–control study conducted in New York City and 10 counties in eastern New Jersey. Details on study recruitment have been described elsewhere (22, 23 (link)). The design of the case–control study recruited Black women and White women in 1:1 ratio; in a later stage, the tissue collection effort was more focused on the enrolled Black women than White women. All participants provided written informed consent. The protocol was approved by all relevant Institutional Review Boards and conducted in accordance with the Declaration of Helsinki. In brief, the cases included patients who self-identified as Black women or as White women between 20 and 75 years of age, able to speak English, with no previous history of cancer other than nonmelanoma skin cancer and who were within 9 months of having received a diagnosis of primary, histologically confirmed, invasive breast cancer or carcinoma in situ. Of patients eligible for inclusion, >95% allowed for the use of their tumor tissue as part of the informed consent form. Clinical and tumor characteristics were obtained from pathology reports. Formalin-fixed paraffin-embedded tissue specimens were used for tissue microarray (TMA) construction that included at least two tumor tissue cores and an adjacent-normal tissue core when available per patient. In total, samples from 865 cases included in TMAs were available for laboratory assays. After immunostaining, tumor tissue cores <25 cells for scoring were excluded. Subsequently, 739 cases (668 invasive breast cancer and 71 carcinoma in situ) who had at least one tumor tissue core scored with any of the mTOR pathway proteins assayed and data on PA variables were retained for statistical analyses. A subset of cases (N = 125) who had adjacent-normal tissue paired with the tumor tissue were also analyzed.