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    Nipple Aspirate Fluid Basic Fibroblast Growth Factor

    Scientific Abstract:
    Background: Early detection of breast cancer has been shown to save lives. The process of angiogenesis plays a critical role in breast cancer growth and metastasis. Breast cancer cells are known to secrete potent angiogenic growth factors and inhibitors. The levels of these factors in the serum and urine of breast cancer patients have been shown to correlate with disease status, once the cancer has been diagnosed. Recently, we have observed that the levels of nipple fluid bFGF (basic fibroblast growth factor, a potent angiogenic growth factor) are significantly elevated in breast cancer patients in comparison with those in controls. Objective/Hypothesis: This proposal aims at determining whether nipple aspirate fluid bFGF can be used as a diagnostic or screening tool for breast cancer. Specific Aims: The specific aims are as follows: Aim 1: To calculate the sensitivity and specificity of nipple aspirate fluid bFGF for diagnosing breast cancer, and Aim 2: To compare nipple aspirate fluid bFGF with standard diagnostic or screening tests for breast cancer. Study Design: We will enroll patients who have an abnormal mammogram and/or ultrasound. The level of bFGF in the nipple aspirate fluids will be determined by an ELISA (enzyme linked immunosorbent assay). Subsequently, the patients undergo a biopsy of the breast abnormality in order to obtain a histological diagnosis. Based on the outcome of cancer on biopsy, the following parameters will be calculated for nipple aspirate fluid bFGF: sensitivity, specificity, and predictive value. We will also use the above parameters to compare nipple aspirate fluid bFGF with standard diagnostic or screening tests for breast cancer (i.e. physical examination and mammogram/ultrasound). Potential Outcomes and Benefits of the Research: This proposal is aimed at developing a simple, non-invasive and inexpensive test that incorporates the latest technology into early breast cancer detection. If the nipple aspirate fluid bFGF test proves to be valid statistically, we do not expect that it would replace the current standard screening tests. However, an abnormally elevated nipple aspirate fluid bFGF may change the current treatment algorithms for many women seen in our clinics. This test on nipple aspirate fluid could be complementary to the current methods used for breast cancer screening. Such a combination could potentially enhance our ability to detect breast cancer early, when it is still curable with existing treatment methods. Overall, a novel test for diagnosing or screening for breast cancer would potentially have a significant impact on this very prevalent disease.

    Lay Abstract:
    Breast cancer is the most frequently diagnosed cancer in women, and is the second most common cause of cancer deaths among American women overall. It has been shown time and again that early detection saves lives, since there is no cure for advanced breast cancer. However, screening mammography misses as much as 50% of the breast cancer cases in young women. Current serum tumor markers for breast cancer are only useful in cases of widespread disease. The patients’ nipple fluid has been largely neglected as a possible source of diagnostic purpose. Recently, we have observed that the levels of nipple aspirate fluid bFGF (basic fibroblast growth factor, a potent factor important in the growth of tumor blood vessels) are significantly elevated in breast cancer patients in comparison with those in patients without cancer. In this proposal, we will carry out studies in order to determine whether nipple aspirate fluid bFGF can be used as a diagnostic or screening tool for breast cancer. Our belief is that the detection of nipple aspirate fluid bFGF could be complementary to the current methods used for breast cancer screening. Such a combination could potentially enhance our ability to detect breast cancer early, when it is still curable with existing treatment methods. The specific aim is to determine the validity of nipple aspirate fluid bFGF in diagnosing breast cancer in patients with an abnormal mammogram and/or ultrasound. Furthermore, nipple aspirate fluid bFGF will be compared to standard diagnostic or screening tests for breast cancer. The validation questions are both scientific and practical. Is this new method statistically valid enough to diagnose or predict breast cancer? And if it is, does this method improve on existing standards of breast cancer screening (physical exam and mammogram), and does it change current breast treatment algorithms? Nipple aspirate fluid bFGF must fulfill both criteria to be useful clinically to women. If the nipple aspirate fluid bFGF proves to be valid statistically, we expect that this test may change the way we treat our patients. We do not ever expect nipple aspirate fluid bFGF to replace the physical exam or the mammogram/ultrasound. A portion of patients with highly suspicious physical exam or radiologic finding(s) should proceed to some type of definitive biopsy procedure. And there are many patients who will choose surgical excision, the most accurate and definitive biopsy procedure, regardless of any test result. However, there is a large number of women in whom a third reliable test would help decide toward the direction of the less invasive (but less accurate) biopsy procedure of FNA (fine needle aspiration) or core needle biopsy, or just short term followup without any biopsy procedures. These women have physical exam or radiologic finding(s) that are low in suspicion. This change in treatment algorithm may potentially decrease both financial and personal costs, since an invasive biopsy is both expensive and traumatic to the patients.