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Background: CD44 and ALDH1 have been recognized as the most widely used markers to identify breast cancer stem cells (BCSCs). However, limited to tissue sample and rare population, BCSCs have always been not easily detected. We aimed to measure CD44 and ALDH1A1 (major contributor to ALDH1 activity) levels in serum and explore the prognostic value in primary breast cancer patients. Methods: This study included 140 primary breast cancer patients with stage I-III. Serum samples were collected before surgery and stored at -80 degrees. CD44 and ALDH1A1 were measured by chemiluminescent assay. Results: High serum CD44 levels (≥ 417.4 ng/mL) were correlated with postmenopausal status ( P = 0.006), estrogen receptor negativity ( P = 0.025), progesterone receptor negativity ( P = 0.002) and adjuvant chemotherapy ( P = 0.003). The mean serum CD44 levels of luminal group (406.4 ± 68.3 ng/mL) were significantly lower than triple negative group (506.8 ± 175.5 ng/mL) ( P &lt; 0.001). There was no correlation between serum ALDH1A1 levels and molecular subtypes. Multivariate analysis revealed that high serum CD44 level (≥ 417.4 ng/mL), was an independent factor for PFS ( P = 0.019) and OS ( P = 0.008). However, serum ALDH1A1 has no impact on either PFS ( P = 0.613) or OS ( P = 0.441). Conclusion: Serum CD44 was an independent prognostic indicator in primary breast cancer. However, serum ALDH1A1 has no impact on survivals and might not be an appropriate candidate to predict prognosis for breast cancer.

Breast cancer stem cell markers CD44 and ALDH1A1 in serum: distribution and prognostic value in patients with primary breast cancer