A Structured Behavioral Intervention to Improve Patient Engagement and Health Outcomes in Invasive Breast Cancer Patients, Carolina Breast Cancer Study Phase 4 (CBCS4) Trial

Inclusion Criteria

• Women (defined as “assigned female at birth”) diagnosed with a first primary invasive breast cancer who are residing at the time of diagnosis in one of the designated study 59 counties between September 1, 2023, and December 31, 2029
• Diagnoses included all invasive epithelial tumors of the breast (breast carcinomas): International Classification of Diseases (ICD) 10 codes: C50.0 to 50.9 * The study excludes skin of breast, excludes in situ breast cancer (breast ductal carcinoma in situ [DCIS] or breast lobular carcinoma in situ [LCIS]), excludes DCIS with micro-invasion to a depth of 1mm (i.e. invasive tumors greater than 1mm are eligible)
• Eligibility for the study will be based upon the date of the biopsy that was used to make the original diagnosis. Fine-needle aspiration (FNA) is not sufficient for diagnosis, so for purposes of eligibility date of FNA will not be used for date of diagnosis
• Patients who are diagnosed with simultaneous bilateral breast cancer (two separate primary invasive tumors discovered at the same time) will be included in the study, and classified based upon the more advanced stage tumor. Patients who are diagnosed with a first invasive breast cancer and a second primary breast cancer (invasive or in situ) within six months of the date of diagnosis of the first invasive tumor will be eligible for the study based upon their first invasive cancer, and will be classified based upon the first invasive tumor. For all such bilateral cases, we will request medical records pertaining to both primary tumors, and the best tumor block from both primary tumors. The first tumor will receive sequence number 01, and the second 02, etc.
• Eligible histologic diagnoses: Invasive ductal carcinomas not otherwise specified (NOS), invasive ductal carcinomas with specific features (tubular, mucinous, medullary, papillary, micropapillary, cribiform), DCIS with focal invasion (greater than 1mm), invasive lobular carcinoma (classic), invasive lobular carcinoma (variant), mixed invasive ductal and lobular, apocrine carcinoma, neuroendocrine carcinoma, inflammatory carcinoma, anaplastic carcinoma, metaplastic carcinoma, undifferentiated or poorly differentiated carcinoma, high grade carcinomas * NOTE: If a patient is diagnosed with DCIS, but had positive lymph nodes on axillary lymph node dissection, then the patient is eligible for the study. Paget's disease is eligible only if accompanied by invasive carcinoma
• Eligibility will be based upon the community diagnosis. Patients must have a biopsy and/or surgery report to establish eligibility. We will not accept fine needle aspirates (FNAs). Patients undergoing neoadjuvant chemotherapy most often undergo a biopsy first, have chemotherapy, and then have surgery. If a patient only has FNA before surgery (rare), the patient will only become eligible for CBCS4 after a biopsy or surgical pathology report is sent to the North Carolina Central Cancer Registry (CCR) following chemotherapy. Some stage IV patients may never have surgery, but at some point they will have a biopsy
• In order to be eligible for CBCS4, a biopsy report is required. In rare instances, women may undergo fine needle aspirate (FNA) only and then initiate neoadjuvant chemotherapy. Since receptors for ER, progesterone receptor (PR) and HER2 cannot be performed on FNA, standard procedure is not to initiate therapy without a biopsy. Some patients presenting at stage IV (about 5% of patients) might never have surgery, but they will have a biopsy that should include ER and PR status. Therefore, we will require a biopsy report and not a surgery report to determine case eligibility
• Patients with FNA only are not eligible for the study. Patients with breast cancer found in a lymph node only (occult primary tumor) are eligible for the study as long as biopsy of the lymph was performed that confirmed invasive breast cancer

Exclusion Criteria

• Excluded (ineligible) histologic diagnoses: Phylloides tumors, sarcomas and other non-epithelial tumors. Metastases from other organs