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4. Diagnosis

Updated August 2016

4.1 Overview

The diagnosis of a breast cancer depends on the presentation of the lesion by mammographic screening, other radiological imaging (such as ultrasound) or by physical presentation. In all cases, it is important to combine the radiologic assessment of the entire affected breast and the contralateral breast with the general health of the woman, examination of the breast and nodal areas, and a pathological diagnosis. The treatment of the breast cancer will depend on combining the results of these investigations. Although most breast lumps are not cancerous, the practitioner must be aware that breast cancer can appear at any age, and if there is any suspicion, a definitive diagnosis should be obtained promptly.

The diagnosis of breast complaints and breast cancer has evolved significantly over the past 20 years with advances in imaging and pathology techniques and increased interdisciplinary management of breast problems. Core needle biopsy of breast lesions is now the standard of care and surgical biopsy should be performed only when core needle biopsy is not possible.3,4,8

A complete review of management of breast complaints and benign breast disease is beyond the scope of this document.  

Breast complaints should be evaluated by physical examination of the breast and axilla, imaging of the breast, and consideration of biopsy- the so called “Triple Test”. In all cases there should be a concordance assessment of the physical exam, imaging, and biopsy results and if these results are not concordant, further investigation is necessary to rule out malignancy.  

History and physical exam

History and physical examination should be performed in patients with breast complaints to determine the nature of clinical presentations, such as clarify features of discharge, assess masses for suspicion for breast cancer, and determine the etiology of breast pain.  

Physiologic nipple discharge should be differentiated from pathologic nipple discharge. The former is characterized as bilateral, involving multiple ducts, is milky/yellow/green in colour and nonspontaneous. This type of discharge does not require diagnostic medical imaging.  Pathologic nipple discharge is unilateral, involves a single duct, is clear/bloody/serosanguinous in colour and spontaneous.15

Physical examination is the first step in the evaluation of breast pain. The location and characteristics of the pain help to differentiate breast pain from chest wall pain. Chest wall pain is commonly located at the costochondral junctions and over the lateral chest wall, rather than in the breast itself. Physiologic breast pain is characterized as cyclical, non-focal and bilateral and is typically due to hormonal or age-related changes. Physiologic and chest wall pain do not require diagnostic breast imaging as pain of this nature has not been shown to correlate with the presence of breast cancer.14 Breast pain that is persistent, non-cyclical, unilateral and, most importantly, focal, may indicate underlying breast pathology.15

Diagnostic imaging is indicated when a breast mass, suspicious skin or nipple changes, or pathologic nipple discharge is confirmed on physical examination. In the absence of suspicious physical examination findings, screening mammography is recommended.  

Imaging

Diagnostic imaging should be requested for patients with pathological clinical exam findings. In general, bilateral diagnostic mammograms and targeted ultrasound are recommended for women over 35. Tomosynthesis is becoming increasingly available and MRI is used for problem solving in particular circumstances. Imaging assessment involves correlating findings on the different imaging modalities. Final guidance regarding further management (e.g. further imaging, clinical follow up, or biopsy) is usually found in breast radiology reports.  

It is recommended that radiologists report the degree of suspicion for breast cancer on imaging studies using a recognized reporting system6 such as the BIRADS system5 as this risk assessment determines the need for an image guided needle biopsy. Imaging that is determined to be negative (BIRADS 1) or benign (BIRADS 2) does not require further follow up. Lesions that are determined to be BIRADS 4 have a risk of malignancy of 2-95% and are recommended for biopsy. Lesions designated BIRADS 5 have a risk of malignancy of >95% and require core needle biopsy and should have surgical excision if the core needle biopsy is not malignant. Lesions that are BIRADS 3 have an estimated risk of malignancy of less than 2% and are recommended to have follow up imaging in 6 months and are followed for 2 years.

It is known that about 10% of breast cancer will not been seen on a mammogram and a negative mammogram  should not be a cause for delay in diagnosis of breast cancer. Any suspicious physical exam findings require further imaging and biopsy.


CategoryManagementLikelihood of cancer
0
Needs additional imaging or prior exams
Recall for additional imaging or obtain prior studies
n/a
1
Negative
Routine Screening
Essentially 0
2
Benign
Routine Screening
Essentially 0
3
Probably Benign
Short interval Follow-up (6 months)
0-2%
4
Suspicious for malignancy
Tissue diagnosis
4a. low suspicion for malignancy- 2-10%
4b. moderate suspicion for malignancy 10-50%
4c. high suspicion for malignancy 50-95%
5
Highly Suspicious for malignancy
Tissue diagnosis
>95%
6
Biopsy proven malignancy
Surgical excision when clinically appropriate
n/a

Table 1.  BIRADS Final Assessment Categories10 

Biopsy

Core needle biopsy (CNB) diagnosis of breast lesions is the preferred initial invasive diagnostic procedure3,4,13, and imaging guidance is recommended to increase accuracy of targeting8. CNB is able to accurately diagnose most breast lesions and results in an improved cosmetic  outcome for the patient, cost savings to the system, and decreases the number of operations that a patient requires.3,4 CNB of breast lesions is now the standard of care and surgical biopsy should be performed only when core needle biopsy is not possible.3,4,8,13 Obtaining preoperative core needle biopsy diagnosis of breast lesions in more than 90-95% of patients is a quality indicator in breast surgery internationally.1,2,8 CNB results are classified as benign, high-risk, or malignant.4,7
      
Concordance assessment of initial investigations

Concordance assessment is an important part of CNB. For an image guided CNB, concordance is the agreement of imaging and histopathological findings such that the histopathology satisfactorily explains the imaging findings.6 Discordance refers to the situation when a breast CNB demonstrates benign histology while the imaging findings are concerning for possible malignancy. Discordance presents a diagnostic situation that requires further evaluation, including the options of (a) repeating CNB, perhaps with consideration of larger gauge or vacuum-assisted techniques, (b) surgical excisional biopsy, or (c) clinical and imaging surveillance.6,7

Failure to resolve imaging-pathology discordance can lead to a delay in breast cancer diagnosis. Imaging-Pathology correlation should be provided by the doctor performing the biopsy6,7 and this is typically done by issuing a radiology-pathology addendum report which should outline whether further investigation, follow up, or surgical excision is recommended.
  
For patients with a clinical presentation, there needs to be correlation between physical exam, imaging, and pathology7 by the clinician who has ordered/reviewed the investigations. If the physical examination remains suspicious for malignancy, but imaging and/or core needle biopsy is benign, then further investigations, such as skin biopsy, surgical biopsy, repeat core needle biopsy or further imaging are necessary to rule out malignancy.  

Borderline or High Risk Lesions on core needle biopsy

Concordance assessment also involves assessing the situation for risk of under-sampling by core needle biopsy. When the chance of this occurring is increased, the lesion is regarded as being a high risk lesion. High risk lesions found on CNB are usually recommended to have surgical excision of the area to rule out malignancy due to under-sampling. The risk of under-sampling varies by diagnosis and is affected by factors such as the number and size of CNB specimens taken, size of lesion, and institution.4,7 Institutions that have documented a low upstage rate to breast cancer following surgical resection for specific diagnoses may offer their patients follow up rather than surgical excision.4,7,9

Surgical excision is recommended/considered for the following CNB results:

Surgical Excision Recommended
Atypical Ductal Hyperplasia
Papillary Lesions with atypia
Radial scar/complex sclerosing lesions
Fibroepithelial lesions with cellular stroma
Mucocele-like lesions
Spindle cell lesions
Pleomorphic LCIS
Surgical Excision Considered
Lobular Neoplasia (classic LCIS and ALH)
Flat Epithelial Atypia/DIN 1a
Papillary lesion without Atypia
Discordance

Concordance assessment after surgical excision

Specimen imaging of fine wire guided excisions is recommended and all breast surgical specimens should be oriented for the pathologist. Concordance assessment is recommended after surgical excision of breast lesions to ensure that the lesion of interest has been accurately targeted and excised. In rare circumstances, the lesion found by the patient was different from the lesion biopsied under imaging guidance and this is suggested by discordance between preoperative diagnosis and surgical pathology. The finding of the core needle biopsy scar in the excised tissue suggests accurate targeting, but this can also be present in adjacent tissue. If there is discordance between the surgical pathology and the preoperative diagnosis, further investigations are indicated and can include further imaging, image guided localization, or surgical re-excision.  Interdisciplinary review is recommended to guide management.  

Image Detected breast abnormalities

Non-palpable breast lesions (masses, calcifications, asymmetries, architectural distortion) can be found on screening mammograms and breast imaging done for other symptoms. The evaluation of such lesions is described above in the "Imaging" section and focuses on assessing risk for malignancy. The BIRADS reporting system and radiology-pathology concordance statements are particularly useful in determining the need for further management and follow up due to the absence of physical examination findings to guide the treating clinician. 

Navigating the diagnostic system and wait times

With the development of increased diagnostic breast imaging options and the introduction of image-guided breast biopsy, patients may need to attend a number of appointments to obtain a diagnosis. It is recommended that patients have their mammograms, breast ultrasound, and ultrasound guided core needle biopsy performed by a consistent radiology group to facilitate comparison, limit duplication, and decrease wait times. When more specialized biopsy or imaging techniques are required such as stereotactic biopsy, MRI, or MRI guided biopsy, the patient may need to attend additional centers.  

The potential for fragmented care and extended wait times has been recognized and the 2012 BC Provincial Breast Health Strategy (BHS)11 has recommended target wait times of 21 days to diagnosis without biopsy and 28 days to diagnosis when biopsy is required. The BHS has also recommended facilitation of necessary investigations and increasing navigation resources for patients to help facilitate a prompt diagnosis.  

The Screening Mammography Program of BC introduced Fast Track booking for evaluation of screen detected lesions in 2010 and many breast diagnostic teams in the province have introduced care pathways and clinics to decrease wait times.  Currently each community has a slightly different system with regards to how breast imaging and biopsies are arranged. Next steps are sometimes facilitated by radiology and sometimes ordered by family physicians. With these divergent approaches pitfalls can arise, particularly if patients have mammograms outside of the usual community. Referring physicians should be aware of these differences and the role they are expected to play in arranging investigations for their patient.

References

  1. Eusoma  http://www.eusoma.org/Engx/Guidelines/Other/OtherMT.aspx?cont=MT
  2. ACS breast centers:  https://www.facs.org/~/media/files/quality%20programs/napbc/2014%20napbc%20standards%20manual.ashx
  3. Kristy Cho, Scott Tyldesley, MD, FRCPC, Caroline Speers, BA, Barbara Poole Lane, MPA,  Karen A. Gelmon, MD, FRCPC, Christine Wilson, MD, FRCPC.  The utilization and impact of core needle biopsy diagnosis on breast cancer outcomes in British Columbia.   Issue: BCMJ, Vol. 56, No. 4, May 2014, page(s) 183-190 Articles
  4. Melvin J. Silverstein, Abram Recht, Michael D. Lagios, Ira J. Bleiweiss, Peter W. Blumencranz, Terri Gizienski, Steven E. Harms, Jay Harness, Roger J. Jackman, V. Suzanne Klimberg, Robert Kuske, Gary M. Levine, Michael N. Linver, Elizabeth A. Rafferty, Hope Rugo, Kathy Schilling, Debu Tripathy, Pat W. Whitworth, Shawna C. Willey.  Image-Detected Breast Cancer: State-of-the-Art Diagnosis and Treatment.  Journal of the American college of Surgeons.  p504–520.  Published online: August 20, 2009
  5. http:www.acr.org/Quality-Safety/Resources/BIRADS      Accessed Sept 4 2016
  6. http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Breast%20imaging     Accessed Aug 1 2016
  7. American Society of Breast Surgeons.  https://www.breastsurgeons.org/new_layout/about/statements/PDF_Statements/Concordance_and_High%20RiskLesions.pdf.  Accessed Jan 9, 2017. 
  8. https://www.breastsurgeons.org/new_layout/about/statements/PDF_Statements/Image-Guided_Percutaneous_Biopsy_Palpable_Nonpalpable.pdf    Accessed Aug 1 2016
  9. Becker AK1, Gordon PB, Harrison DA, Hassell PR, Hayes MM, van Niekerk D, Wilson CM  Flat ductal intraepithelial neoplasia 1A diagnosed at stereotactic core needle biopsy: is excisional biopsy indicated?  AJR Am J Roentgenol. 2013 Mar;200(3):682-8. doi: 10.2214/AJR.11.8090.
  10. Sickles EA, D’Orsi CJ, Bassett LW et al. ACR BI-RADS Atlas, In: ACR BI-RADS Atlas, Breast Imaging Reporting and Data System: Mammography. 5th ed. Reston, VA: American College of Radiology, 2013
  11. Lynn Pelletier:  Breast Health Strategy Summary Report 2012.  Provincial Health Services Association.  
  12. https://www.breastsurgeons.org/new_layout/about/statements/PDF_Statements/PerformancePracticeGuidelines_ExcisionalBreastBiopsy.pdf
  13. https://www.breastsurgeons.org/statements/QM/ASBrS_Preoperative_diagnosis_of_breast_cancer.pdf
  14. American College of Radiology.   ACR Appropriateness Criteria: Breast Pain https://acsearch.acr.org/docs/3091546/Narrative/.  Accessed Mar 10, 2017. 
  15. Padilla-Thornton A, Farrel J, Gordon P, et al.  Diagnosis of Breast Cancer:  Current Concepts.  BCMJ.  In Press.  


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