New Palpable Mass ~ Algorithm 2

Breast Cancer Diagnostic Algorithms for Primary Care Providers
(Third Edition, June 2005)

New Palpable Mass
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Introduction to the work-up of a New Palpable Mass ~ Algorithm 2

Management of the patient with a breast mass varies according to age, history and clinical findings. Detection of a breast mass often creates anxiety for the woman and her family, requiring sensitive provider/patient communication. Important questions to consider when assessing the index of suspicion of a breast mass (lesion) detected on CBE include:

• Is it an asymmetrical finding in both breasts?
• Is it a three dimensional discrete palpable mass?
• What is the location and depth?
• Is it mobile or fixed?
• What is the size and shape?
• What is the consistency?
• Is it tender or non-tender?

Normal glandular tissue is generally mirrored in the contralateral breast. A discrete palpable mass is three-dimensional, different from surrounding tissues and usually asymmetric. Clinical signs that are suggestive of benignity, but are not diagnostic, include a mass that is soft, rubbery and mobile. Features suggestive of malignancy include a mass that feels firm or hard, is fixed, has an irregular shape, is solitary, and feels much different from the surrounding breast tissue (Barton, 1999; Goodson, 1996).

CBE is a screening method, not a diagnostic test. Regardless of age, every clinically suspicious lesion requires further evaluation. CBE finds 4% to 7% of cancers that are normal or benign on mammography (Green 2003, Bobo 2000, Beyer 2003, Georgian-Smith 2000). Thus, an abnormal CBE in the presence of a negative mammogram requires further follow-up. The leading cause of physician delay in the diagnosis of breast cancer continues to be inappropriate judgment that a mass is benign without performing a biopsy. Reducing delay in diagnosis requires less reliance on CBE to determine the benignity of a mass as well as less reliance on benign mammographic reports in deciding not to biopsy a mass (Goodson, 2002). Physical exam alone is approximately 70% accurate; mammography alone is approximately 85% accurate; minimally invasive tissue diagnosis alone is approximately 95% accurate. While physical exam and mammogram alone can detect many cancers, no single test by itself allows for detection of all breast cancers. The best clinical approach to the diagnosis and management of patients with a palpable mass is the combination of all three tests – physical exam, radiographic imaging and pathology (biopsy or FNA). This diagnostic triad is known as the "triple test." The diagnostic accuracy of these three tests taken together approaches 100% (Morris, 2002; Vetto, 2003). Clinicians should select the "triple test" method as it helps make an evidence-based decision about clinical management. If one of the "triple test" components is discordant, the entire diagnosis is uncertain and each of the "triple test" findings will need to be reviewed before proceeding.

Pre-menopausal Women
In patients younger than 30 years of age, or patients who are pregnant, ultrasound may be the first or sole breast imaging modality performed (Mehta, 2003 and Baker, 2000). For patients 30-49 years of age with a new palpable mass, a cyst is the most likely diagnosis and can be confirmed or ruled-out by fine needle aspiration (FNA) or ultrasound (a diagnostic imaging modality). If the degree of suspicion is very low (the palpable mass is a "ridge" and is two-dimensional, rather than three-dimensional), it is acceptable to repeat the screening CBE at a more optimal time of the menstrual cycle. Any palpable mass that persists and has not been proven to be a simple cyst, must receive additional diagnostic work-up until a final diagnostic status is determined.

Post-menopausal Women
Since the risk of breast cancer increases with age, clinicians need to be more suspicious of a dominant mass or asymmetric thickening in the breasts of postmenopausal women. Cystic findings decrease after menopause, although cysts, pain, and discharge can be found in women taking hormone replacement therapy. Diagnostic imaging evaluation is usually the first-line investigation of a palpable breast mass in postmenopausal women.

Regardless of age, it is important to request a diagnostic imaging evaluation for a palpable mass, and NOT a screening mammogram.

Flowchart Notes and Footer

NOTE 2A: Upon detection of a palpable breast mass, the PCP may suspect a simple cyst. This diagnosis must be confirmed with ultrasound or fine needle aspiration/biopsy. A breast mass that completely resolves by needle aspiration of non-bloody fluid can be considered insignificant if there are no signs of recurrence four to six weeks post-aspiration (Pruthi, 2001). Ultrasonography depicts the fluid within cysts and can diagnose cysts with a diameter as small as 2-3 mm in small breasts. Ultrasound is less sensitive in large breasts due to the fatty breast tissue. Although multiple cysts commonly occur, a woman with breast cysts needs to be advised to seek medical advice whenever a new mass arises. Neither the clinician nor the woman can automatically assume that a new mass is “just another cyst.” Non-palpable cysts detected by mammography and confirmed by ultrasound do not need to be aspirated unless they are symptomatic and cause pain. A cyst that recurs more than two times within four to six weeks, contains bloody fluid, or leaves a residual palpable mass post-aspiration demands a diagnostic imaging evaluation. In this situation, the radiologist should be informed that an aspiration was undertaken prior to the imaging procedure. Cysts with internal debris or thick material require further follow-up.

NOTE 2B: Clinician confidence level in performing cyst aspiration may vary. Proceed with diagnostic imaging evaluation (e.g., ultrasound) if routine aspiration is not offered in your practice.

NOTE 2C: A clinically suspicious mass may have one or more features consistent with cancer, such as firmness, irregularity, or solitary. Sometimes such masses are fixed and associated with skin retraction. Any asymmetrical finding should be cause for concern (Barton, 1999; Goodson, 1996). Patients with suspicious findings should be referred to a breast surgeon immediately.

NOTE 2D: Patients with a new palpable mass and Negative (BI-RADS ® category 1) diagnostic imaging evaluation result should at minimum have a repeat CBE within thirty days. The negative imaging result indicates that there were no radiographically identified lesions, but does not preclude existence of a non-radiographically evident lesion. The follow-up CBE will allow the PCP to determine whether the palpable mass is persistent. If the mass is not persistent, there should be another repeat CBE in 3-6 months. If this confirms that the mass is no longer present, the patient can then return to routine screening intervals. Patients with negative imaging, in whom the mass persists at a follow-up CBE, should be referred to a breast specialist for decisions regarding follow-up interval or need for biopsy.

NOTE 2E: Patients with a Benign finding (BI-RADS ® category 2) on mammogram should have a repeat CBE within thirty days. This allows the practitioner to correlate the physical findings with the diagnostic imaging evaluation and assure that the finding is concordant. The imaging finding identifies the anticipatory physical finding as benign; if there is no correlation between the imaged mass and the palpable mass, the patient should be referred to a breast specialist for decisions regarding interval follow-up or tissue biopsy. Mammography should be performed using a radio-opaque marker on the skin over a palpable lesion to assist in determining if the palpable mass corresponds to the mammographically identified lesion. A discordant mammographic finding may represent a separate lesion, which may need further evaluation in addition to a work-up for the original palpable mass. Careful correlation of the physical exam and the diagnostic imaging evaluation is critical to assure appropriate and timely follow-up. If the imaging findings show a simple cyst, it can be aspirated during a follow-up CBE if required to alleviate discomfort.

NOTE 2F : The American College of Radiology does not recommend the assignment of a Probably Benign (BIRADS category 3) result as the final diagnostic imaging evaluation for a patient with a palpable mass. This may occur if the radiologist is unaware of the CBE findings. If the results of your CBE screening indicate a palpable mass and you receive a BIRADS category 3 final diagnostic imaging evaluation, contact the radiologist for further consultation.

Footer:
*Diagnostic Imaging Evaluation should be accompanied by standard screening mammography of both breasts if screening mammography has not been conducted within the recommended timeframe. Diagnostic Imaging Evaluation will often include diagnostic mammogram and breast ultrasound, but can also include any radiographic imaging procedure recommended by the radiologist. A final BI-RADS category will be assigned to the case based on the results of all diagnostic imaging procedures. Women should return to routine screening once the diagnostic and/or treatment cycle is completed.

References

Baker, J. A., Soo, M. S. (2000). The evolving role of sonography in evaluating solid breast masses. Semin Ultrasound CT MR, 21(4), 286-96.

Barton, M., Harris, R., Fletcher, S. (1999). Does this patient have breast cancer? The screening clinical breast examination: Should it be done? How? Journal of the American Medical Association, 282 (13), 1270-1280.

Beyer, T., Moonka, R. (2003). Normal mammography and ultrasonography in the setting of palpable breast cancer. American Journal of Surgery , 185 (5), 416-419.

Bobo, J. K., Lee, N. C., Thames, S.F. (2000). Findings from 752,081 clinical breast examinations reported to a national screening program from 1995 through 1998. Journal of the National Cancer Institute , 92(12), 971-976.

Georgian-Smith, D., Taylor, K. J. W., Madjar, H., Goldberg, B., Merritt, C. R. B., Bokobsa, J., et al. (2000). Sonography of palpable breast cancer. Journal of Clinical Ultrasound, 28(5), 211-216.

Goodson, W. H. (1996). Clinical breast examination. Western Journal of Medicine, 164, 355–358.

Goodson, W., & Moore, D. H. (2002). Causes of physician delay in the diagnosis of breast cancer. Archives of Internal Medicine, 162(12), 1343-1348.

Green, B. B., & Taplin, S. H. (2003). Breast cancer screening controversies. The Journal of the American Board of Family Practice, 16, 233-241.

Mehta, T. S. (2003). Current uses of ultrasound in the evaluation of the breast. Radiology Clinics of North America , 41(4), 841-856.

Morris, K. T., Vetto, J. T., Petty, J. K., Lum, S. S., Schmidt, W. A., Toth-Fejel, S., et al. (2002). A new score for the evaluation of palpable breast masses in women under age 40. American Journal of Surgery, 184, 245-247.

Pruthi, S. (2001). Detection and evaluation of a palpable breast mass, Mayo Clinic Proceedings , 76(6), 641-647.

Vetto, J., Pommier, R., Schmidt, W., Wachtel, M., DuBois, P., Jones, M., et al. (2003). Use of the “Triple Test” for palpable breast lesions yields high diagnostic accuracy and cost savings. American Journal of Preventative Medicine, 24(2), 128-135.

Updated: November, 2007.

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