The Breast Cancer Diagnostic Algorithms for Primary Care Providers were originally developed by the California Department of Health, and are re-printed with permission from that agency, and adapted for Vermont by Marie Wood, M.D., U.V.M. Seven separate algorithms are available to guide the evaluation of women with breast abnormalities or suspicious findings detected during a woman's breast cancer screening visit. Also with permission, go to the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer Screening and Diagnosis.

Algorithms are systematically developed decision points based on scientific data and professional consensus, and visually guide the clinician.

Typically, algorithms:

• Use a stepwise, branching approach to guide practice that is based on screening and diagnostic results and patient characteristics;
• Promote "if, then" decision-making so that the clinical pathway can adapt to a variety of test results;
• Allow for clinician assessment to affect decision points along a "branching logic" tree; and
• Are useful when clinical judgments determine different choices in clinical pathways.

Benefits of Algorithms

By using consensus-driven clinical pathways, clinicians minimize their professional liability. The overall benefits include:

• An efficient way to incorporate accumulated scientific knowledge into daily practice;
• Adherence to standard guidelines by using algorithms that are kept current through regular revision;
• Improvement of quality of care by reducing missed diagnoses; and

• Efficient use of valuable health resources.

Although the benefits of using algorithms appear straightforward, not all clinicians use them regularly. Some perceived barriers are related to clinic management systems and others are related to clinician attitudes and historical practice.

1. Risk Assessment Table

This Risk Assessment Table yields a qualitative assessment of risk with the outcome of either average or increased risk for breast cancer. It does not include all possible risk factors or provide a quantitative estimate of risk.

Other risk assessment tools estimate a woman's quantitative breast cancer risk. Four of the most widely used mathematical models and mentioned above such as the Gail, Claus, BRCAPRO, and Tyrer- Cuzick (also called IBIS).

The Breast Cancer History and Risk Assessment: Patient Information Form offers a systematic approach for gathering and recording key information needed for determining a patient’s breast cancer risk and plan of action as well. It is intended to be completed by the patient and reviewed by the clinician with the patient. The questionnaire can be used in conjunction with the Risk Assessment Table below.

 1. Notes

Note 1A. The Gail Model is accessible through an interactive computer program online. Based on age and other risk factor information provided by the user, the program will estimate a woman's risk of developing invasive breast cancer during the next 5-year period and up to age 90 (lifetime risk). The program, intended primarily for use by health professionals, is available on the website of the National Cancer Institute.

Note 1B. Non-proliferative lesions include fibrosis, cysts, mild hyperplasia, non-sclerosing adenosis, simple fibroadenoma, phyllodes tumor (benign), a single papilloma, fat necrosis, mastitis, duct ectasia, and benign lumps or tumors (lipoma, hamartoma, hemangioma, hematoma, neurofibroma).

Note 1C. Proliferative lesions without atypia include usual ductal hyperplasia, complex fibroadenoma, sclerosing adenosis, several papillomas or papillomatosis, and radial scar.

Note 1D. Studies suggest that the use of combined (estrogen and progesterone) hormone replacement therapy (HRT) for more than two or three years may increase breast cancer risk. Within five years of stopping combined HRT, a woman's risk appears to return to that of the general population (ACS, 2009a, Sep).

Note 1E. Mutations in several other genes have been associated with hereditary breast and/or ovarian cancer (e.g., TP53, PTEN, STK11/LKB1 and CDH1). However, the majority of hereditary breast cancers can be accounted for by mutations in the BRCA1 and BRCA2 genes.

Note 1F. Other genetic syndromes that predispose to the development of breast cancer include Cowden Syndrome, Li-Fraumeni Syndrome, Peutz-Jeghers Syndrome, ataxia-telangiectasia, and hereditary diffuse gastric cancer.

Note 1G. In patients with one or more of these factors, a thorough genetic cancer risk assessment is warranted. A thorough assessment will determine the patient's level of risk and provide individualized screening recommendations.

Note 1H. There is a lack of consensus among guideline developers regarding the optimal frequency and ages to begin and end mammography screening. For women with average risk for developing breast cancer, the U.S. Preventive Services Task Force recommends biennial mammography screening starting at age 50 and ending at age 74 (USPSTF, 2009), while the American Cancer Society recommends annual mammography screening starting at age 40 and continuing for as long as a woman is in reasonably good health (Smith et al., 2003). Ladies First recommends that healthcare providers discuss the optimal screening schedule with their patients, based on an individual's breast cancer risk factors, presence of symptoms, and risks and benefits of mammography screening.

Note 1J. Risk assessment models that are largely dependent on family history include the Claus, BRCAPRO, Tyrer-Cuzick (also called IBIS), and others. For a review of these and other breast cancer risk assessment models, see Amir, Freedman, Bostjan and Evans (2010).

Note 1K. Patients may consider bilateral mastectomy and other risk-reducing surgeries for at-risk organs consistent with the diagnosed inherited breast cancer syndrome.

Also, with permission go to the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer Risk Reduction.

2. Palpable Breast Mass

Key  Messages:

A palpable breast mass is a common clinical finding. While most masses are benign, any suspicious finding should be thoroughly evaluated until cancer is ruled out.

Depending upon patient age, risk factors, medical history, and exam characteristics, evaluation may include mammography, ultrasound, fine needle aspiration biopsy, core needle biopsy, or surgical biopsy.

Diagnostic imaging, rather than screening, should be ordered by the primary care provider (PCP) for any suspicious palpable mass.

Clinical breast examination (CBE) can detect breast cancers that are not found with diagnostic imaging. In a study of women with breast cancer who initially presented with palpable breast masses, nearly 4% received normal or benign findings on both mammography and ultrasonography (Beyer & Moonka, 2003). Therefore, an abnormal CBE in the presence of a BI-­RADS® Category 1 or 2 requires further investigation. While surgical biopsy is considered the gold standard, minimally invasive biopsy techniques have become the optimal first step.

The Triple Test is the recommended approach to the evaluation of a palpable breast mass, especially solid lumps. When findings from CBE, breast imaging, and biopsy are concordant (in agreement), diagnostic accuracy approaches 100% (Vetto et al., 1995). If findings from any one test differ from the others, the diagnosis is uncertain and further investigation is required.

Core needle biopsy (CNB) is the method of choice for obtaining diagnostic tissue for patients with breast lesions where the differential diagnosis includes cancer. Fine needle aspiration biopsy (FNAB) is another technique but due to significant limitations, FNAB is not recommended when CNB is available.   

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.

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).

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.

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.

The notes below pertain to Algorithm #2 flow chart and were provided by the California Dept of Health to assist in interpreting the chart.

2. Notes

 
3. Abnormal Screening Mammogram with Normal CBE

There are two types of mammograms: screening and diagnostic. Screening mammograms are used for women who have no clinical signs or breast complaints. Diagnostic mammograms are used to evaluate an abnormal clinical finding or an area of concern from an abnormal screening mammogram. The ordering of a screening mammogram when a diagnostic mammogram is required can cause a delayed diagnosis of breast cancer.

Mammograms should only be performed in facilities certified under the Mammography
Quality Standards Act (MQSA) with FDA accreditation. As an MQSA certified facility, all mammographic imaging results are required to be reported using the Breast Imaging Reporting and Data System (BI-­RADS®).

BI-­RADS® was developed by the American College of Radiology (ACR) to standardize mammography reports. It is also used for breast ultrasound and MRI.

BI-­RADS® categories provide a characterization of the imaging results and have implications for follow-­up and management. In total, there are seven BI-­RADS® assessment categories. Categories 1 -­ 6 are used for complete assessments (ACR, 2003).

 BI-­RADS® Category 0 (Assessment is Incomplete) - Used for indicating that further tests and/or records are needed before a final assessment category can be assigned.

 BI-­RADS® Category 1 (Negative) — Continue routine interval screening.
 
 BI-­RADS® Category 2 (Benign Findings) — Continue routine interval screening.

 BI-­RADS® Category 3 (Probably Benign) — Initial short-­interval follow-­up examination, usually in 6 months, followed by another examination in 6 months, then annually until stability is demonstrated for a minimum of 2 to 3 years. Women at increased risk should be referred to a breast specialist. Category 3 is not recommended for
screening mammograms; it is intended for use with diagnostic mammograms only.

BI-­RADS® Category 4 (Suspicious Abnormality) — Requires an intervention, usually biopsy.

BI-­RADS® Category 5 (Highly Suggestive of Malignancy) — Requires biopsy.

BI-­RADS® Category 6 (Proven Malignancy) — Used for biopsy-­proven cancer. (Not applicable to this algorithm.)

Evaluations that use multiple imaging procedures (mammography plus breast ultrasound and/or MRI) may be assigned a separate BI-­RADS® category for each procedure. In such cases, appropriate management is based on the BI-­RADS® category that reflects the
highest level of suspicion for cancer (ACR, 2003).

Primary care clinicians are encouraged to discuss with patients their BI-­RADS® assessment category and its meaning with regard to appropriate follow-­up and likelihood of breast cancer.

The notes below pertain to Algorithm #3 flow chart and were provided by the California Dept of Health to assist in interpreting the chart.

3. Notes

Note 3A. Screening mammogram results of Negative (BI-­RADS® Category 1) or Benign (BI-­RADS® Category 2) prompt routine interval screening for women with normal clinical breast examinations.

Note 3B. A BI-­RADS® Category 0 (Assessment is Incomplete) may be used temporarily for a screening mammogram when the final assessment requires additional views and/or tests, or a review of previous imaging results. Category 0 should never be used as a final assessment category.

Note 3C. The American College of Radiology (ACR) advises against the use of Probably Benign (BI-­RADS® Category 3) for screening mammograms. Per ACR (2003), "such findings are generally identified on baseline screening or on screening for which previous examinations are unavailable for comparison. Immediate evaluation with additional mammographic views and/or ultrasound is required to render a Category 3, probably benign assessment."

Note 3D. A BI-­RADS® Category 4 (Suspicious Abnormality) requires an intervention, usually biopsy. (The use of three subdivisions are optional for this category, with 4a reflecting the lowest level of suspicion for cancer and 4c reflecting the highest.) Category 5 (Highly Suggestive of Malignancy) always requires biopsy. The particular method of biopsy is based on a combination of factors that include the characteristics of the abnormality as well as the available resources at a given medical facility. For brief descriptions of the various types of biopsy, see Algorithm 7, Breast Biopsy.

Note 3E. A BI-­RADS® Category 3 requires a differential assessment of risk. (See the Risk Assessment Table, page 3, to determine if the patient is at increased risk for breast cancer.) A woman with a diagnostic imaging result of Category 3 who is at increased risk for breast cancer should be referred to a breast specialist (i.e., a health professional with special education and/or experience in breast cancer). A referral can also be offered to any woman who is concerned about her results and desires further information.

Note 3F. For BI-­RADS® Category 3, the vast majority of findings are managed with an initial short-­interval examination, usually in 6 months, followed by another examination in 6 months, then annually until stability is demonstrated for a minimum of 2 to 3 years. There may also be occasions when a biopsy is done as a result of patient and/or clinician concerns.

 4, Spontaneous Unilateral Nipple Discharge

Profiles of Ladies First

Nipple discharge is the third most frequently reported breast complaint, after breast pain and breast mass (Hussain, Policarpio & Vincent, 2006). The vast majority of nipple discharges are normal (related to lactation) or otherwise benign.

A detailed history and careful physical examination are the important first steps in the evaluation of nipple discharge. A discharge that is spontaneous (occurs without stimulation), unilateral, and uniductal is more concerning than a discharge without these characteristics. Bloody or guaiac-­positive discharge raises the possibility of cancer, although the character of the fluid is generally unreliable for differentiating among the various possible causes.

A nipple discharge related to lactation is considered normal. It is typically bilateral and the fluid is milky. Normal milk secretion can continue for up to one year after the cessationof breastfeeding.

Galactorrhea describes a nipple discharge that has the appearance of milk but is unrelated to lactation. Most often, the discharge is spontaneous, multiductal, and bilateral. Galactorrhea occurs in approximately 20% -­ 25% of women (Pena & Rosenfeld, 2001) and is rarely associated with cancer. Possible causes are many, including certain medications, hypothyroidism, pituitary adenomas, breast stimulation, chest wall irritation, and numerous other origins.

Pathologic nipple discharge is also characterized as spontaneous but is typically unilateral and uniductal. Fluid that contains blood, or less frequently, fluid that is clear, raises concern. However, even with these features, most cases of pathologic nipple discharge are due to benign causes.

The most common causes of a pathologic nipple discharge are benign intraductal papilloma, duct ectasia, and fibrocystic changes. An estimated 5% -­ 15% are due to an underlying malignancy (Golshan & Iglehart, 2010b). The risk of cancer is greater for women ages 40 and older.

Every patient with pathologic nipple discharge should be referred for diagnostic imaging evaluation. While imaging may detect an underlying abnormality, negative results should not deter further evaluation. In women with this symptom, imaging studies are not sufficiently reliable for identifying all cancers or high risk lesions (Golshan & Iglehart, 2010b).

Cytologic examination of nipple discharge is considered useful in some cases; however, as with imaging, a negative result should not stop further evaluation. In the majority of cases, a histological diagnosis by surgical procedure is needed.

References

Apantaku, L. (2000). Breast cancer diagnosis and screening. American Family Physician , 62, 596-602, 605-6.

Florio, M. A., Fam, F., Giacombbe, G., Pollicino, A., Scarfo, P. (2003). Nipple discharge: personal experience with 2,818 cases. Chirurgia Italiana , 55(3), 357-363. Abstract obtained from PubMed, PMID: 12872570.Morrow, M. (2000). Physical examination of the breast. In J. R. Harris, M. E. Lippman, M. Morrow, & C. K.

Morrow, M. (2000). Physical examination of the breast. In J. R. Harris, M. E. Lippman, M. Morrow, & C. K. Osborne, (Eds.), Diseases of the breast (2nd ed., pp. 67-70). Philadelphia: Lippincott, Williams and Wilkins.

Morrow, M. (2000). The evaluation of common breast problems. American Family Physician, 61, 2371-2378, 2385.

Sheen-Chen, S. M., Chen, H. S., Chen, W. J., Eng, H. L., Sheen, C. W., Chou, F. F. (2001). Paget disease of the breast — an easily overlooked disease? Journal of Surgical Oncology, 76(4), 261-265.

The notes below pertain to Algorithm #4 flow chart and were provided by the California Dept of Health to assist in interpreting the chart.

4. Notes

Note 4A. Spontaneous nipple discharge occurs unprovoked and without stimulation. Nipple discharge that occurs only with stimulation is rarely associated with cancer.

Note 4B. The physical examination should attempt to obtain fluid from the nipple by using a warm compress and gentle pressure at the base of the areola. If discharge is present on exam, diagnostic imaging evaluation is indicated. Diagnostic imaging is also indicated
for a patient who reports a history of bloody discharge (including the report of finding stains of blood on her bra or underclothing), even if bilateral. Fluid that is clear and watery can also be associated with cancer. For bilateral and milky nipple discharge (including yellow, green, or grey), consider causes related to breast stimulation, medications, or endocrine abnormalities.

Note 4C. A spontaneous nipple discharge that persists should be referred to diagnostic imaging.

Note 4D. Regardless of negative imaging results, a persistent and spontaneous discharge requires follow-­up with a breast specialist. It remains necessary to determine and treat the cause. A guaiac-­ positive (evidence of blood) or uniductal discharge should be referred to a surgical clinician experienced in breast disorders.

Note 4E. Biopsy should be performed by terminal duct excision. The goal is to excise the duct from which the discharge occurs along with as little additional tissue as possible. 

5. Breast Skin Changes/Nipple Retraction

A thorough history and clinical breast examination (CBE) are the first steps to the assessment of the patient who presents with skin changes or nipple retraction. Important questions to consider include: A thorough history and clinical breast examination (CBE) are the first steps to the assessment of the patient who presents with skin changes or nipple retraction. Important questions to consider include: 

How long has the change been present?
Is there an associated palpable mass or mammographic abnormality?
Is it a unilateral finding?

Diagnostic imaging is the next line of investigation for suspicious skin or nipple changes (even if no mass is palpable on CBE). However, a negative or benign imaging result must not preclude referral to a breast specialist. A clinical abnormality of the breast requires further evaluation.

Eczema must be distinguished from Paget's disease of the nipple, an uncommon but serious form of breast cancer. Despite clinical differences, Paget's disease should be considered until proven otherwise.

Patients with a unilateral nipple retraction of recent onset, even if slight, require a thorough diagnostic evaluation. Unilateral nipple retraction is more suspicious than bilateral nipple inversion. Congenital nipple inversion is insignificant.

Skin redness associated with breast pain and swelling is seen with mastitis or infected skin lesions. These symptoms can also be signs of inflammatory breast cancer (IBC). If the suspicion for IBC is low, a 7-­10 day course of antibiotics may be indicated. If symptoms are not completely (100%) resolved, IBC should be suspected and diagnostic imaging is required.

IBC may be confused with certain inflammatory noninfectious diseases, such as atopic dermatitis, psoriasis, eczema, systemic lupus erythematosus, and vasculitis. Treatment with steroids is not recommended when diagnosis is in doubt since the clinical signs of IBC may be temporarily improved by steroids.

IBC is characterized by rapid onset of erythema (occupying at least one-­third of the breast), edema, fine dimpling 9peau d'orange), and/or a warm breast. IBC may or may not be accompanied by a distinct palpable mass. IBC is an aggressive disease and usually progresses rapidly. The incidence of IBC in U.S. women ranges from 1% -­ 5% (Dawood et al, 2010).

Mammographic characteristics of IBC are often diffuse and subtle;? skin and trabecular thickening are the most common but are nonspecific (i.e., can also be associated with mastitis). It is critical that a proper clinical history be included in the request for diagnostic imaging and/or any other follow-­up for ensuring a prompt and accurate diagnosis.

Adapted from Hughes, L.E., Mansel, R.E. & Webster, d.J.T. (1989). benign Disorders and Diseases of the Breast: Concepts and Clinical Management. London: Balliere Tindall.

References

Cristofanilli, M., Singletary, E. S., Hortobagyi, G. N. (2004). Inflammatory breast carcinoma: the sphinx of breast cancer research. Journal of Clinical Oncology , 22, 381-383.

Fu, W., Mittel, V. K., Young, S. (2001). Paget disease of the breast: analysis of 41 patients. American Journal of Clinical Oncology, 24(4), 397-400.

Hughes, L. E., Mansel, R. E., Webster, D. T.J. (2000). Benign disorders and diseases of the breast — concepts and clinical management (2nd ed.). New York: WB Saunders.

Lev-Schelouch, D., Sperber, F., Gat, A., Klausner, J., Gutman, M. (2003). Paget's disease of the breast [Electronic Version]. Harefuah , 142(6), 433-437, 485.

Marcus, E. (2004). The management of Paget's disease of the breast. Current Treatment Options in Oncology, 5(2), 153-60.

National Cancer Institute. (2002). Cancer Facts. Paget's disease of the breast: questions and answers. [Brochure].

Sun, Q., Zhou, Y. D., Huang, H.Y. (2003). Diagnosis and treatment of Paget's disease of the breast: report of 33 cases. Zhongguo Yi Xue Ke Xue Yuan Xue Bao, 25(1), 93-95.

The notes below pertain to Algorithm #5 flow chart and were provided by the California Dept of Health to assist in interpreting the chart.

5. Notes

Note 5A. Treatment with topical steroid cream for nipple/areolar rash is not recommended prior to diagnostic evaluation. Steroids can temporarily improve symptoms and mask the clinical signs of an

Note 5B. A 7-­10 day course of antibiotics with follow-­up may be initiated for skin changes that appear consistent with infection. If symptoms are not completely (100%) resolved, prompt diagnostic imaging evaluation is required. A negative or benign imaging result must not preclude referral to a breast specialist.

Note 5C. The particular method of biopsy is based on a combination of factors that include the characteristics of the abnormality as well as the available resources at a given medical facility. For brief descriptions of the various types of biopsy, see Algorithm 7, Breast Biopsy.
 

6. Breast Pain in a Non-lactating Woman

Breast pain affects 60% -­ 70% of women at some point during their lives. In rare instances, pain is a sign of breast cancer. The most common causes of breast pain are fibrocystic changes and hormonal changes related to menstruation, pregnancy, and menopause. Pain is also common with breast cysts and infection (mastitis).

Physical activities or trauma and certain types of medications can also cause breast pain.
The differential diagnosis of breast pain requires a clinical breast examination (CBE) and careful history. Important considerations include:

• Onset, location and severity
• Relationship to the menstrual cycle
• Related physical activities
• History of trauma
• Hormonal influences (contraceptives, HRT, pregnancy, etc.)
• Medications associated with breast pain (hormonal, antidepressant, antipsychotic, anxiolytic, antihypertensive and cardiac, antimicrobial agents, and others) 

Breast pain is generally classified as cyclic, noncyclic or extramammary. Cyclic pain is most common.            

Cyclic pain is related to the timing of the menstrual cycle and often accompanied by swelling. It is usually bilateral and frequently located in the upper, outer quadrants of the breast, sometimes radiating to the underarm. It is often described as diffuse, dull, full, aching, and heavy.

Noncyclic pain can be either constant or intermittent. It is most often unilateral and localized to one area of the breast, but it may also radiate outward. The pain may be described as sharp, burning, throbbing, or sore.

Extramammary breast pain is experienced as originating from the breast, but the actual origin is elsewhere (most frequently, the chest wall).

Distinguishing the source of the pain is usually straightforward;? inconsistent or multiple sources may present more of a challenge. Cardiac, pulmonary, and gastrointestinal causes need to be excluded.

Breast cancer must be considered in patients with well-­localized, non-­cyclic pain. In studies of women presenting with focal pain as the primary (or only) symptom, a diagnosis of breast cancer has been reported for 1.2% -­ 6.7% of cases (Smith, Pruthi & Fitzpatrick, 2004).

For most women, treatment of breast pain consists of symptom relief and reassurance. When both CBE and diagnostic imaging studies are normal, the probability of breast cancer is estimated at only 0.5%
(Smith et al., 2004). 

References

American College of Radiology (ACR). (2003). Appropriate imaging work-up of palpable breast masses. ACR Appropriateness Criteria. Retrieved Sept. 29, 2005, from http://www.acr.org/s_acr/sec.asp?CID=1200&DID=15041 *

American College of Radiology (ACR). (2003). BI-RADS® - Ultrasound. Reston, VA: Author.

American College of Radiology. (2003). Breast imaging reporting and data system (BI-RADS) (4th ed.). Reston, VA: Author.

Institute for Clinical Systems Improvement. (2003). Breast Disease, Diagnosis of (formerly Breast Cancer Diagnosis). ICSI Healthcare Guideline. Retrieved from http://www.icsi.org/knowledge/detail.asp?catID=29&itemID=168.

Khan, S. A., Apkarian, A. V. (2002). The characteristics of cyclical and non-cyclical mastalgia: a prospective study using a modified McGill pain questionnaire. Breast Cancer Research and Treatment, 5(2), 147-157.

Morrow, M. (2000). Physical examination of the breast. In J. R. Harris, M. E. Lippman, M. Morrow, & C. K. Osborne, (Eds.), Diseases of the breast (2nd ed., pp. 67-70). Philadelphia: Lippincott, Williams and Wilkins.

The notes below pertain to Algorithm #6 flow chart and were provided by the California Dept of Health to assist in interpreting the chart.

6. Notes

Note 6A. Distinguish between cyclic and non-­cyclic breast pain. Cyclic pain is typically bilateral and described as diffuse, dull, full, aching, and heavy. Non-­cyclic pain tends to be unilateral and well-­localized. It may be described as sharp, burning, throbbing, or sore.

Note 6B. First-­line treatments, such as oral or topical nonsteroidal anti-­inflammatory agents, may be offered for pain relief while awaiting the results from diagnostic imaging
procedures.

Note 6C. Although there are no radiologic features associated with breast pain, diagnostic imaging studies are used to exclude the rare presence of a subclinical breast cancer.

Note 6D. A BI-­RADS® Category 3 result (Probably Benign) requires a differential assessment of risk. (See the Risk Assessment Table, page 3, to determine if the patient is at increased risk for breast cancer.) A patient with a diagnostic imaging result of Probably Benign, who is also at increased risk for breast cancer, should be referred to a breast specialist. A referral can also be offered to any woman who is concerned about her results and desires further information from a breast specialist.

Note 6E. For BI-­RADS® Category 3, the vast majority of findings will be managed with an initial short-­term follow-­up examination in 3 to 6 months, followed by additional
examinations until stability is demonstrated (for a minimum of 2 years). There may be occasions when a biopsy is done (e.g., patient request or clinical concerns). Evidence from published studies indicates the need for biopsy if the lesion increases in size or undergoes morphologic change (ACR, 2003).

Note 6F. The particular method of biopsy is based on a combination of factors that include the characteristics of the abnormality as well as the available resources at a given medical facility. For brief descriptions of the various types of biopsy, see Algorithm 7, Breast Biopsy. 

7. Management of Breast Biopsy Results

The pathologic findings from a biopsy must fully explain the clinical and/or the imaging findings that prompted the biopsy ("triple test"). Clinical/radiologic/histologic discordance occurs when the CBE and/or imaging findings are not explained by the final pathology. When repeat imaging studies or clinical exam indicate that the original radiographic or clinical finding may not have been adequately sampled ("discordant triple test result"), further biopsy is needed. Clinical/radiologic/histologic discordance carries a rate of malignancy that can be as high as 40-50% (Morris, 2003). Therefore, if the results are discordant, or if the clinician is not sure, the patient must undergo further evaluation by a breast specialist. Various options are available for obtaining concordance. These include radiology consultation, repeat image-guided biopsy, or surgical consultation. For example, a woman with a palpable mass within 2 cm of visual nipple retraction and a pathology result of normal or fibrocystic change represents discordance between the clinical findings and the pathology report (regardless of the diagnostic imaging result). The patient needs a repeat biopsy.

References

Bassett L.W. (2002, March). Options in breast biopsy. Imaging Economics.

Liberman, L., Drotman, M., Morris, E. A., LaTrenta, L. R. (2000). Imaging-histologic discordance at percutaneous breast biopsy (an indicator of missed cancer). Cancer, 89(12), 2538-2546.

Morris, A. M., Flowers, C. R., Morris, K. T., Schmidt, W. A., Pommier, R. F., Vetto, J. T. (2003). Comparing the cost-effectiveness of the triple test score to traditional methods for evaluating palpable breast masses. Medical Care, 41, 962-971.

Salami, N., Hirschowitz, S., Nieberg, R., Apple, S. (1999). Triple test approach to inadequate fine needle aspiration biopsies of palpable breast lesions. Acta Cytologica, 43(3), 339-343.

Shaw, V. I., Raju, U., Chitale, D., Deshpande, V., Gregory, N., Strand, V. (2003). False negative core needle biopsies of the breast. Cancer, 97, 1824-1831.

The notes below pertain to Algorithm #7 flow chart and were provided by the California Dept of Health to assist in interpreting the chart.

7. Notes

Note 7A. When biopsy finds that an abnormality is not malignant but concerning, the patient should be referred to a breast specialist for further evaluation. Such abnormalities are sometimes associated
with a malignancy.

Note 7B. If physical findings and/or diagnostic imaging results are suspicious for a malignancy, then a negative biopsy finding must be considered discordant. It may represent a false negative result.

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