ASSOCIATION OF INTRON 4 VNTR (4A/B) POLYMORPHISM OF THE ENDOTHELIAL NITRIC OXIDE SYNTHASE GENE WITH THE INCIDENCE OF BREAST CANCER IN IRAQI WOMEN.

BackgroundAlthough the prognosis for operable breast cancers is reportedly worse if serum carcinoembryonic antigen (CEA) and cancer antigen 15-3 (CA15-3) levels are above normal, the usefulness of this prognosis is limited due to the low sensitivity and specificity; in addition, the optimal cutoff levels remain unknown.MethodsA total of 1076 patients who were operated for breast cancers (test set = 608, validation set = 468) without evidence of metastasis were recruited, and their baseline and postoperative serum CEA and CA15-3 levels were analyzed. The optimal cutoff values of CEA and CA15-3 for disease-free survival (DFS) were 3.2 ng/mL and 13.3 U/mL, respectively, based on receiver operating characteristic curve and area under the curve analyses.ResultsThe DFS of patients with high CEA levels (CEA-high: n = 191, 5-year DFS 70.6%) was significantly worse (p < 0.0001) than that of CEA-low patients (n = 885, 5-year DFS 87.2%). There was a significant difference in DFS (p < 0.0001) between CA15-3-high and CA15-3-low patients (n = 314 and n = 762, respectively; 5-year DFS 71.8 vs. 89.3%). Significant associations between DFS and CA15-3 levels were observed irrespective of the subtypes. Multivariable analysis indicated that tumor size, lymph node metastasis, tumor grade, and CEA (p = 0.0474) and CA15-3 (p < 0.0001) levels were independent prognostic factors (hazard ratio [HR] 1.520, 95% confidence interval [CI] 1.005–2.245 for CEA; HR 2.088, 95% CI 1.457–2.901 for CA15-3).ConclusionsThese findings suggest that CEA and CA15-3 levels might be useful for predicting the prognosis of patients with operable early breast cancer irrespective of the subtype. Serum levels at baseline may reflect tumor characteristics for metastatic potential even when these levels are within the normal ranges.

Previous studies have indicated that carcinoembryonic antigen (CEA) and cancer antigen 15–3 (CA15-3) levels are both independent prognostic factors in breast cancer. However, the utility of CEA and CA15-3 levels as conventional cancer biomarkers in patients with triple-negative breast cancer (TNBC) remains controversial. The current study was performed to explore the predictive value of pre-therapeutic serum CEA and CA15-3 levels, and nomograms were developed including these serum cancer biomarkers to improve the prognostic evaluation of TNBC patients. Pre-therapeutic CA15-3 and CEA concentrations were measured in 247 patients with stage I–IV TNBC. Kaplan-Meier analysis showed that TNBC patients with high levels of both CEA and CA15-3 had shorter overall survival (OS) and disease-free survival (DFS) rates than those in the low-level groups (p<0.05). Multivariate analysis suggested that pre-therapeutic CA15-3 and CEA levels are independent predictive elements for OS (p = 0.022 and p = 0.040, respectively) and DFS (p = 0.023 and p = 0.028, respectively). In addition, novel nomograms were established and validated to provide personal forecasts of OS and DFS for patients with TNBC. These novel nomograms may help physicians to select the optimal treatment plans to ensure the best outcomes for TNBC patients.

PurposeCancer antigen 15-3 (CA15-3) is a serum tumor marker for breast cancer (BC) extensively used in clinical practice. CA15-3 is non-invasive, easily available, and a cost-effective tumor marker for immediate diagnosis, monitoring and prediction of BC recurrence. We hypothesized that an elevation of CA15-3 may have prognostic impact in patients with early BC with normal serum CA15-3 level.MethodsThis was a retrospective cohort study, which included patients with BC who received curative surgery at a comprehensive single institution between 2000 and 2016. CA15-3 levels from 0 to 30 U/mL were considered normal, and patients who had CA15-3 > 30 U/mL, were excluded from the study.ResultsThe mean age of study participants (n = 11,452) was 49.3 years. The proportion of participants with elevated CA15-3 ≥ 1 standard deviation (SD) compared with the previous examination during follow-up was 23.3% (n = 2,666). During the follow-up (median follow-up 5.8 years), 790 patients experienced recurrence. The fully-adjusted hazard ratio (HR) for recurrence comparing participants with stable CA15-3 level to subjects with elevated CA15-3 level was 1.76 (95% confidence interval [CI], 1.52–2.03). In addition, if the CA15-3 was elevated ≥ 1 SD, the risk was much higher (HR, 6.87; 95% CI, 5.81–8.11) than in patients without elevated CA15-3 ≥ 1 SD. In sensitivity analysis, the recurrence risk was consistently higher in participants with elevated CA15-3 levels than in participants without elevated CA15-3 levels. The association between elevated CA15-3 levels and incidence of recurrence was observed in all subtypes and the association was stronger in patients with N+ than in patients with N0 stage (p-value for interaction < 0.01).ConclusionThe results of the present study demonstrated that elevation of CA15-3 in patients with early BC and initial normal serum CA15-3 levels has a prognostic impact.

Tumor markers such as carcinoembryonic antigen (CEA) and cancer antigen 15-3 (CA15-3) are widely used for monitoring breast cancer. However, the prognostic efficacy of preoperative elevations of CEA and CA15-3 levels in breast cancer patients remains controversial. We retrospectively analyzed the clinicopathological parameters of 149,238 patients in the Korean Breast Cancer Society Registry Database who underwent surgery between January 2000 and December 2015. The patients with elevated CA15-3/CEA levels had worse overall survival (OS) than the patients with normal CA15-3/CEA levels. For the luminal A subtype, the CA15-3- and CEA-elevated group had a hazard ratio (HR) of 2.14 (95% CI 1.01-4.55). The CA15-3-elevated group had an HR of 2.38 (95% CI 1.58-3.58) and the CEA-elevated group had an HR of 1.79 (95% CI 1.20-2.68) compared to the normal group. For the luminal B subtype, the CA15-3- and CEA-elevated group had an HR of 3.99 (95% CI 2.23-7.16), whereas the CA15-3-elevated group had an HR of 2.38 (95% CI 1.58-3.58) and the CEA-elevated group had an HR of 1.79 (95% CI 1.20-2.68). For the HER2 subtype, elevated CEA level was the only independent prognostic factor. However, for the triple-negative breast cancer (TNBC) subtype, elevated preoperative CEA and CA15-3 levels were not significant prognostic factors for OS. Preoperative CEA and CA15-3 levels showed varying prognostic ability according to breast cancer subtype. Preoperative CA15-3 and CEA elevation are significant prognostic factors for luminal breast cancer, but they were not significant factors for TNBC.

Background & AimsThe utility of measuring carcinoembryonic antigen(CEA) and cancer antigen 15-3 (CA15-3) levels in patients with breast cancer remains controversial. The present study aims to investigate the prognostic value of preoperative serum CEA and CA15-3 levels in breast cancer patients.MethodsSerum preoperative CEA and CA 15-3 concentration levels were measured in a total of 432 breast cancer patients. The association of tumor markers levels with clinicopathological parameters and outcomes were analyzed.ResultsElevated serum levels of CEA and CA15-3 were identified in 47 (10.9%) and 60(13.9%) patients, respectively. Larger tumor size, advanced axillary lymph nodal and TNM stage exhibited higher proportion of elevated CEA and CA15-3 levels. The elevation of CEA levels was significantly greater in patients with HER2 positive tumors, and the elevation of CA15-3 levels was significantly greater in ER negative breast patients. Univariate and multivariate Cox’s regression analysis revealed that elevated preoperative CEA and CA 15-3 levels were independent prognostic factors for DFS and OS. When considering the combination of both markers levels, patients with both elevated markers presented the worst survival. Independent prognostic significance of elevated preoperative serum CEA and CA15-3 levels were reconfirmed in Luminal B breast cancer.ConclusionsPreoperative serum levels of CEA and CA15-3 are independent prognostic parameters for breast cancer.

BackgroundThe aim of this study was to evaluate the relationship between ultrasonographicfindings and serum progesterone and cancer antigen-125 (CA-125) levels in threatened miscarriage and to predict pregnancy outcome.Materials and MethodsIn a prospective comparative case-control study, serum CA-125 andprogesterone levels were measured for 100 pregnant women with threatened miscarriage whoattended the outpatient clinic or the causality department of Obstetrics and Gynecology at KasrEl-Aini Hospital, Giza, Egypt, during the period from March 2013 to October 2013. Ultrasound was performed for fetal viability, crown-rump length (CRL), gestational sac diameter(GSD) and fetal heart rate (FHR). The patients were followed up and divided into two groupsbased on the outcome: 20 women who miscarried (group 1), and 80 women who continuedpregnancy (group 2). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy were tested for CA-125 and progesterone levels inprediction of the pregnancy outcome. Correlation of these chemical markers with the ultrasound markers was also examined.ResultsIn the group that miscarried, CA-125 level was significantly higher (P<0.001)and serum progesterone level was significantly lower (P<0.001). For prediction ofthe outcome of pregnancy, the cut-off limit of 31.2 IU/ml for CA-125 level yieldedsensitivity, specificity and an overall accuracy of 96.2, 100 and 99.4% respectively.The cut-off limit of 11.5 ng/ml for progesterone level yielded sensitivity, specificity and an overall accuracy of 97.5, 100 and 99.8% respectively. CA-125 level hada negative correlation with progesterone level and FHR levels (r=-0.716, P<0.001)and (r=-0.414, P<0.001) respectively. Serum progesterone level correlated with GSD(r=0.521, P<0.001) and with CRL (r=0.407, P<0.001) and FHR (r=0.363, P<0.001).CA-125 level was significantly higher in the group that showed hematoma as compared with the group without hematoma (P<0.001). Also, serum progesterone levelwas significantly lower in the group that showed hematoma as compared with thegroup without hematoma (P=0.017).ConclusionSerum CA-125 and progesterone levels are valid early predictors of the outcome of pregnancy in women with threatened miscarriage. They are correlated with someultrasonographic markers (GSD, CRL, and FHR).

The early detection of breast cancer enables the use of less aggressive treatment and increases patient survival. The transmembrane glycoprotein mucin 1, which is also known as cancer antigen 15-3 (CA15-3), is aberrantly glycosylated and overexpressed in a variety of epithelial cancers, and serves a crucial role in the progression of the disease. CA15-3 is currently used as a marker of breast cancer. In the present study, CA15-3 concentrations in saliva and blood of patients with breast cancer were evaluated to test new assays to detect salivary CA15-3 in addition to ELISA and its diagnostic value. To the best of our knowledge, there are no previous reports of the use of chemiluminescence assay (CLIA) and electrochemiluminescence assay (ECLIA) in saliva. Saliva and blood were collected on the same day from patients with breast cancer (n=26) and healthy controls (n=28). For each subject, the level of serum CA15-3 was measured using ECLIA, and the level of salivary CA15-3 was measured using ECLIA, CLIA and enzyme-linked immunosorbent assay (ELISA). ELISA and CLIA were able to detect CA15-3 in saliva; however, ECLIA could not detect salivary CA15-3. There was no significant difference between the mean serum and salivary CA15-3 levels in patients with breast cancer or healthy controls. The levels of CA15-3 were highest for luminal breast cancer subtypes and stage IV cases. A moderate correlation was observed between salivary and serum CA15-3 levels as measured by ELISA in breast cancer patients (r=0.56; P=0.0047). The results demonstrated that ECLIA was not a good method to detect salivary CA15-3, although it is the gold standard for detecting serum CA15-3. The presence of CA15-3 in saliva was confirmed, and this will be useful in future research. Further investigations are necessary to confirm the ability to detect salivary CA15-3 and its correlation with serum CA15-3.

The aim of the study was to investigate the relationship between serum carcinoembryonic antigen (CEA), cancer antigen 15-3 (CA15-3), and cancer antigen 125 (CA125) levels and traditional clinicopathological factors in patients with early invasive breast cancer in Xinjiang, and the influence of those serum markers on the prognosis of patients with different molecular subtypes. We conducted a retrospective study based on the clinical data of 2,940 invasive breast cancer patients who were diagnosed and treated at the Affiliated Cancer Hospital of Xinjiang Medical University from 2015 to 2019. Firstly, in this study, preoperative serum CEA, CA15-3, and CA125 levels were divided into elevated and normal groups based on the optimal cut-off values. Secondly, Chi-square test was used to analyze the correlation between the elevated and normal groups of CEA, CA15-3, and CA125 and traditional clinicopathological factors. Finally, Cox regression model was also used to evaluate the effect of preoperative CEA, CA15-3, and CA125 elevated groups on the prognosis of patients with different molecular subtypes compared with normal groups. The optimal cut-off values for preoperative CEA, CA15-3, and CA125 were 4.32 ng/mL, 23.10 U/mL and 29.80 U/mL, respectively. The elevated group of preoperative CEA, CA15-3, and CA125 patients usually had larger tumors (tumor size: T2-4), later clinical staging (TNM stage: II-III), and higher histological grading (histological grade: II-III). Univariate analysis showed that the overall survival (OS) of preoperative CEA, CA15-3, and CA125 patients in the elevated group was lower than that in the normal group (P < 0.0001), the 5-year OS was 76.63% vs. 95.35%, 74.34% vs. 95.60%, and 83.73% vs. 94.71%, respectively. Multivariate analysis revealed that for the luminal A, compared with the normal group, the hazard ratios (HRs) of preoperative CEA, CA15-3, and CA125 elevated groups were 6.475 (95% confidence interval (CI): 1.850 - 22.66), 5.192 (95% CI: 1.153 - 23.38), and 7.294 (95% CI: 1.152 - 46.18), respectively. However, for the luminal B, elevated levels of CEA, CA15-3, and CA125 were not independent prognostic factors for OS. For the human epidermal growth factor receptor-2 (HER2)-enriched, the HR of preoperative CA15-3 elevated group was 3.155 (95% CI: 1.325 - 7.509). Additionally, for the triple-negative breast cancer, the HR of preoperative CEA elevated group was 2.390 (95% CI: 1.247 - 4.583). High levels of CEA, CA15-3, and CA125 were positively correlated with increased tumor load. Preoperative CEA, CA15-3, and CA125 levels may have different prognostic effects on patients with different molecular subtypes. Particularly, preoperative elevated levels of CEA have a significant adverse impact on the prognosis of luminal A and triple-negative patients, while preoperative elevated levels of CA15-3 have an adverse effect on the prognosis of luminal A and HER-positive patients.

Serum levels of CEA and CA15-3 in different molecular subtypes and prognostic value in Chinese breast cancer

Background and Aims Assessing volume status in heart failure (HF) and end-stage chronic kidney disease (CKD) is challenging. Plasma volume expansion is an early step in the pathophysiology of decompensated HF and an independent risk factor for death and HF hospitalization, and should be addressed early. Evaluating plasma volume, especially its variation with diuretic therapy, can be a useful clinical tool for guiding decongestive therapy. There's a growing need for accurate and simple tools to guide clinician decisions on patient volume management. Cancer antigen 125 (CA125), a glycoprotein produced in mesothelial cells in the pericardium, pleura, or peritoneum, is primarily associated with ovarian and gynecological malignancies. Recent studies link CA125 to inflammation and congestion. In acute HF, elevated CA125 is associated with fluid overload indicators like increased central venous and pulmonary wedge pressure. Elevated CA125 in acute HF patients is linked to worse outcomes in death and hospital stay length. Evidence supports CA125-guided therapy in acute HF, but its role in managing chronic volume overload is still uncertain. We aim to assess the relationship between CA125 levels and estimated plasma volume (ePV). Method A retrospective unicentric observational study was conducted between June 2022, and April 17, 2023, at the Renocardiac clinic of a tertiary hospital. Clinical data were extracted from electronic patient records. CKD staging was determined following the Kidney Disease Improving Global Outcomes (KDIGO) classification. ePV was calculated using the Kaplan-Hakim formula. CA125 and ePV were assessed for the same patient in 2 different visits and their variation was calculated. The correlation between CA125 and ePV, as well as CA125 and ePV variation, was evaluated using Spearman's rank correlation coefficient for bivariate analysis, conducted with IBM SPSS®. Results This study comprised 65 patients, totaling 124 hospital visits. The patient demographic was 67.7% male, with a mean age of 76.4 (±12.47) years. In terms of CKD staging, 48.5% were classified as KDIGO 5, 40.6% as KDIGO 4, 9.4% as KDIGO 3, and 1.5% as KDIGO 2. HF etiology distribution included 59% ischemic, 9.8% hypertensive, 6.5% valvular, and 24.5% other causes. The mean ejection fraction was 37.35 (±12.36)% and 19% had preserved ejection fraction; 75% of them were treated with prognostic-modifying medication, including SGLT2 inhibitors. This proportion was lower (19%) in patients with reduced ejection fraction, receiving ACE/angiotensin ± neprilysin inhibitor + mineralocorticoid receptor inhibitor + beta-blocker + SGLT2 inhibitor. During the follow-up period, 13 hospitalizations, 1 major adverse cardiovascular event (MACE), and 5 deaths were recorded. The mean CA125 level was 193.98 (±154.55) U/mL, and patients had a mean ePV of 2.41 (±1.19) L. A significant positive correlation was found between CA125 levels and ePV (r = 0.355, p = 0.000). However, there was no significant correlation between the variation of CA125 and ePV levels between visits (p = 0.535). Conclusion This study focuses on a population with limited implementation of disease-modifying therapy due to advanced CKD, complicating the clinical management of volume status, kidney function, potassium levels, and long-term prognosis in both CKD and HF. CA125 shows potential clinical utility as a marker of congestion, aiding clinicians in assessing volume status by correlating with plasma volume. However, this study found no correlation between CA125 variation and changes in plasma volume. The outpatient nature of the studied population, typically euvolemic, may hinder assessing the relationship between CA125 and ePV changes. Future studies with larger sample sizes are essential to clarify this relationship and potentially identify volume-expanded patients early.

Role of preoperative serum CA-125 and fibrinogen levels in predicting lymph node metastasis, myometrial invasion, and lymphovascular space invasion in patients with endometrial cancer.

BACKGROUND: Cancer antigen 125 (CA125) is a membrane bound glycosylated mucin which has been reported to be the most promising biomarker for ovarian cancer screening. However, results from two large randomized trials comparing screening with CA125 and transvaginal ultrasound to usual care have shown no clinically significant difference in ovarian cancer mortality. A major limitation of CA125 as an ovarian cancer screening biomarker has been low specificity and variation between individuals by personal characteristics. Identifying personal characteristics that influence CA125 levels could be used to create personalized thresholds for CA125 thereby improving its performance as an ovarian cancer screening biomarker. We developed and conducted internal and external validation of two prediction models (linear and dichotomous) of circulating CA125 among postmenopausal women using 28,842 controls without ovarian cancer in four large population-based studies. METHODS: We identified controls from three prospective cohort studies, including Prostate, Lung, Colorectal, and Ovarian (PLCO, n=26,981), European Prospective Investigation into Cancer and Nutrition (EPIC, n=861), and the Nurses' Health Studies (NHS, n=164) as well as one population-based case-control study, the New England Case Control Study (NEC, n=1,000). CA125 was measured using the CA125II assay in PLCO, NHS, and NEC. Meso Scale Discovery (MSD) platform was used to measure CA125 in EPIC. The MSD assay values were recalibrated to the CA125II scale based on 534 NEC controls with both measurements. CA125 levels were log-transformed to achieve normal distribution or dichotomized by the upper limit of normal (35 U/ml). The prediction models were developed and internally validated using postmenopausal controls in PLCO, and then were externally validated using postmenopausal controls in EPIC, NHS and NEC. The prediction models were developed using stepwise linear or logistic regression with &amp;lt;0.15 as significance level for entry and retention considering factors which have been previously reported to be associated CA125 in postmenopausal women as candidate predictors (age, race, body-mass index (BMI), smoking status and duration, age at menarche, oral contraceptive use, party, age at menopause, time since menopause, hormone replacement therapy (HRT) use and duration, family history of ovarian or breast cancer, previous history of cancer, previous history of benign ovarian cyst, history of endometriosis). We then evaluated the performance of the model in the independent validation datasets. RESULTS: The linear CA125 prediction model included age, race, BMI, smoking status and duration, hysterectomy, parity, age at menopause, and duration of HRT use as predictors, explaining 5% of the variability of log-transformed CA125 levels. The correlation coefficient of the measured and predicted log-transformed CA125 was 0.18 in the PLCO testing dataset, and showed comparable correlations across the independent validation datasets (0.14-0.16). The dichotomous CA125 prediction model included age, race, BMI, duration of HRT use, and hysterectomy as predictors with an AUC of 0.63 in the PLCO testing dataset and 0.71 in NEC. CONCLUSION: We developed linear and dichotomous circulating CA125 prediction models in postmenopausal women that can form the foundation for creating personalized thresholds of CA125. However, other factors should be considered to increase the predictive capacity of the model. Citation Format: Naoko Sasamoto, Ana Babic, Bernard A. Rosner, Renée T. Fortner, Allison F. Vitonis, Hidemi Yamamoto, Raina N. Fichorova, Daniel W. Cramer, Rudolf Kaaks, Shelley S. Tworoger, Kathryn L. Terry. DEVELOPMENT AND VALIDATION OF CIRCULATING CA125 PREDICTION MODEL IN POSTMENOPAUSAL WOMEN WITHOUT OVARIAN CANCER [abstract]. In: Proceedings of the 12th Biennial Ovarian Cancer Research Symposium; Sep 13-15, 2018; Seattle, WA. Philadelphia (PA): AACR; Clin Cancer Res 2019;25(22 Suppl):Abstract nr DP-013.

Background: Breast cancer, the most common cancer, is the leading cause of cancer-related deaths among women globally. To effectively reduce mortality, it has become a hot topic to find prognostic indicators that are highly correlated with poor prognosis of breast cancer in early stages. Therefore, this study aimed to explore the levels of serum cancer antigen 15-3 (CA15-3), cancer antigen 125 (CA125), and tissue polypeptide specific antigen (TPS) in individuals with breast cancer and to elucidate the relationship between these markers and clinicopathological factors, as well as their impact on disease prognosis. Methods: This study included 140 subjects diagnosed with breast cancer (breast cancer subgroup), 120 subjects with breast cancer benign lesions (breast benign disease subgroup), and 120 healthy controls (control subgroup). The clinical data and blood samples were collected from all study subjects. Furthermore, the serum levels of CA15-3, CA125, and TPS were evaluated using corresponding enzyme linked immunosorbent assay (ELISA) kits. The correlation between serum indexes and clinicopathological factors was analyzed. Additionally, the 3-year survival rate of breast cancer patients was assessed using the Kaplan-Meier method. Results: A statistically significant difference was observed in the serum CA15-3, CA125, and TPS levels across three subgroups: breast subgroup, benign breast disease subgroup, and control subgroup ( p &lt; 0.05), with higher levels observed in the breast subgroup followed by benign breast disease subgroup. Furthermore, their levels were correlated with pathological type, tumor node metastasis classification tumor node metastasis (TNM) stage, lymph node metastasis, and histological grade ( p &lt; 0.05, p &lt; 0.001). Moreover, these markers were identified as independent risk factors for breast cancer using multivariate Logistic regression analysis ( p &lt; 0.05). The probability of survival of breast cancer subjects in high CA15-3 level subgroup, high CA125 level subgroup and high TPS level subgroup was notably lower than that in low level subgroup, which was shown by Kaplan-Meier analysis ( p &lt; 0.05). Conclusion: The serum levels of CA15-3, CA125, and TPS are significantly elevated in subjects with breast cancer, and their expression levels are correlated with pathological type, TNM stage, lymph node metastasis, and histological grade. These tumor markers can be used as predictors of breast cancer prognosis.

Prognostic value of HE4 in advanced-stage, high-grade serous ovarian cancer: Analysis of HE4 kinetics during NACT, predicting surgical outcome and recurrence in comparison to CA125

Cancer antigen15-3 (CA15-3) is utilized as a tumor marker in breast cancer. In the metastatic situation, it has been regarded as having a predictive role. However, the usefulness of serum CA15-3 in preoperative breast cancer remains argumentative. Therefore, this study aimed to estimate the association of preoperative serum CA15-3 level with the clinico-pathological characteristics in Iraqi women patients with breast tumor and their efficiency for the prediction of primary breast cancer. Preoperative CA15-3 levels were assessed by ELISA technique in 60 Iraqi women with breast tumor (30 with primary breast cancer and 30 with benign breast tumor) before surgery and treatment, as well as 30 healthy controls. In addition, the clinico-pathological characteristics information of all the patients was reported. CA15-3 level showed a significant difference between its level in the sera of primary breast cancer women in comparison to the benign breast tumor women (p &lt;0.001) and healthy control women one (p &lt;0.001). The area under the curve (AUC) of CA15-3 for discriminating patients with primary breast cancer and healthy control subjects was 0.720 (95% CI: 0.589 to 0.828). Furthermore, the present study showed that higher preoperative CA15-3 level was significantly associated with a larger tumor size and lymph node metastasis. This means that elevated CA15-3 is correlated with an increased tumor burden, suggesting its predictive value.