Breast Cancer Screening & Diagnosis Pathway Map - Cancer Care Ontario

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Breast Cancer Screening & Diagnosis Pathway Map Version 2015.11 Disclaimer The pathway map is intended to be used for informational purposes only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to clinical judgment and actual practice patterns may not follow the proposed steps set out in the pathway map. In the situation where the reader is not a healthcare provider, the reader should always consult a healthcare provider if he/she has any questions regarding the information set out in the pathway map. The information in the pathway map does not create a physician-patient relationship between Cancer Care Ontario (CCO) and the reader.

Pathway Map Preamble Target Population Women who meet criteria for the Ontario Breast Screening Program (OBSP) or who present with symptoms of breast cancer. The OBSP is intended for individuals who do not demonstrate any symptoms or previously diagnosed breast cancer. Pathway Map Considerations The OBSP provides high quality breast cancer screening free-of-charge in Ontario. The OBSP is developed based on the guidelines developed by the Canadian Task Force on Preventative Health Care, CMAJ. 2011;183(17):1991–2001. For more information on the OBSP refer to Healthcare Provider Resources – Breast Screening The OBSP requires that a set of minimum standards for breast screening be adhered to: Ultrasound Standards and MRI Standards It is presumed that the patient is assessed clinically throughout the entire pathway map. It is presumed that at each step along the pathway map, the risks and benefits of screening are discussed with the patient. Primary care providers play an important role in the cancer journey and should be informed of relevant tests and consultations. Ongoing care with a primary care provider is assumed to be part of the pathway map. For patients who do not have a primary care provider, Health Care Connect, is a government resource that helps patients find a family doctor or nurse practitioner. Throughout the pathway map, a shared decision-making model should be implemented to enable and encourage patients to play an active role in the management of their care. For more information see Person-Centered Care Guideline and EBS #19-2 Provider-Patient Communication* Hyperlinks are used throughout the pathway map to provide information about relevant CCO tools, resources and guidance documents. The term ‘health care provider’, used throughout the pathway map, includes primary care providers and specialists, nurse practitioners, and emergency physicians. * Note. EBS #19-2 is older than 3 years and is currently listed as ‘For Education and Information Purposes’. This means that the recommendations will no longer be maintained but may still be useful for academic or other information purposes. Confidential Draft For Review Only Version Version 2015.10 yyyy.mm Page Page 22 of of 10 10 Pathway Map Legend Shape Guide Colour Guide Intervention Primary Care Decision or assessment point Supportive and End of Life Care Patient (disease) characteristics Pathology Consultation with specialist Exit pathway map Diagnostic Assessment Program (DAP) X Surgery X Breast Cancer Screening & Diagnosis Pathway Map or Off-page reference Patient path Radiation Oncology Medical Oncology R Referral Radiology W Wait time indicator time point Multidisciplinary Cancer Conference (MCC) Genetics or High Risk Cancer Clinics Line Guide Required Possible Pathway Map Disclaimer This pathway map is a resource that provides an overview of the treatment that an individual in the Ontario cancer system may receive. The pathway map is intended to be used for informational purposes only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to clinical judgment and actual practice patterns may not follow the proposed steps set out in the pathway map. In the situation where the reader is not a healthcare provider, the reader should always consult a healthcare provider if he/she has any questions regarding the information set out in the pathway map. The information in the pathway map does not create a physician-patient relationship between Cancer Care Ontario (CCO) and the reader. While care has been taken in the preparation of the information contained in the pathway map, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability. CCO and the pathway map’s content providers (including the physicians who contributed to the information in the pathway map) shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the pathway map or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the pathway map does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the pathway map. This pathway map may not reflect all the available scientific research and is not intended as an exhaustive resource. CCO and its content providers assume no responsibility for omissions or incomplete information in this pathway map. It is possible that other relevant scientific findings may have been reported since completion of this pathway map. This pathway map may be superseded by an updated pathway map on the same topic. CCO retains all copyright, trademark and all other rights in the pathway map, including all text and graphic images. No portion of this pathway map may be used or reproduced, other than for personal use, or distributed, transmitted or "mirrored" in any form, or by any means, without the prior written permission of CCO.

Pathway Glossary Breast Cancer Screening & Diagnosis Pathway Map Version 2015.10 Page 3 of 10 The pathway map is intended to be used for informational purposes only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to clinical judgment and actual practice patterns may not follow the proposed steps set out in the pathway map. In the situation where the reader is not a healthcare provider, the reader should always consult a healthcare provider if he/she has any questions regarding the information set out in the pathway map. The information in the pathway map does not create a physician-patient relationship between Cancer Care Ontario (CCO) and the reader. Pathway Map Glossary IBIS – an evaluation tool that uses a woman’s family history to calculate the likelihood of her carrying a deleterious mutation in BRCA 1/2 and calculates the risk of developing breast cancer. For more information visit http://www.ems-trials.org/riskevaluator/ BOADICEA (Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm) – an evaluation tool used to calculate the risk of breast and ovarian cancer in a woman based on her family history. For more information visit http://ccge.medschl.cam.ac.uk/boadicea/ BI-RADS (Breast Imaging Reporting and Data System) – a reporting system developed by the American College of Radiology to report the results of ultrasounds, mammograms and MRIs. BI-RADS assessment categories include: Management Recommendations Assessment Categories For Mammography For MRI For Ultrasound Category 0 - Incomplete Additional imaging evaluation and/or comparison with no previous examinations Additional imaging Additional imaging Category 1 - Negative Routine mammography screening Routine breast MRI screening Routine screening Category 2 - Benign Routine mammography screening Routine breast MRI screening Routine screening Category 3 – Probably benign Short-interval (6-month) follow-up or continued surveillance mammography Short-interval (6 month) follow-up Short-interval (6 month) follow-up or continued surveillance Tissue diagnosis Tissue diagnosis Tissue diagnosis Tissue diagnosis Tissue diagnosis Tissue diagnosis Surgical excision when clinically appropriate Surgical excision when clinically appropriate Surgical excision when clinically appropriate Category 4 – Suspicious 4A - Low suspicion 4B - Moderate suspicion 4C - High suspicion Category 5 – Highly suggestive of malignancy Category 6 – Proven malignancy Adapted from D’Orsi CJ, Sickles EA, Mendelson EB, Morris EA et al. ACR BI-RADS Atlas, Breast Imaging Reporting and Data System. Reston, VA, American College of Radiology; 2013

Primary Care Assessment for Risk Appropriate Screening Breast Cancer Screening & Diagnosis Pathway Map Version 2015.10 Page 4 of 10 The pathway map is intended to be used for informational purposes only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to clinical judgment and actual practice patterns may not follow the proposed steps set out in the pathway map. In the situation where the reader is not a healthcare provider, the reader should always consult a healthcare provider if he/she has any questions regarding the information set out in the pathway map. The information in the pathway map does not create a physician-patient relationship between Cancer Care Ontario (CCO) and the reader. Patient self-refers to OBSP OBSP Screening Locations F I J K P S Asymptomatic Eligibility and risk assessment to determine appropriate screening2 (e.g. family and clinical history) CCO Cancer Screening Recommendations Potential High Risk (Genetic assessment required to determine eligibility) Women may be eligible for high risk screening if they are asymptomatic, are 30-69 years of age AND meet one of the following criteria: First degree relative of a carrier of a gene mutation (e.g. BRCA1, BRCA2) and has not had genetic counselling or testing A personal or family history of at least one of the following: o Two or more cases of breast cancer and/or ovarian cancer in closely related relatives o Bilateral breast cancers o Both breast and ovarian cancer in the same woman o Breast cancer at 35 years of age o Invasive serous ovarian cancer o Breast and/or ovarian cancer in Ashkenazi Jewish families o An identified gene mutation (e.g. BRCA1, BRCA2) in any blood relatives o Male breast cancer Women at High Risk – Summary of Evidence From Page 5, 7 or 9 Status Visit to Primary Care Provider1 Average Risk Women are considered eligible for average risk screening if they are asymptomatic and meet all of the following: Are 50-74 years of age3 Have no personal history of breast cancer Have not had a screening mammogram within last 11 months No history of breast implants CCO Cancer Screening Recommendations Known High Risk (Eligible for direct entry into OBSP High Risk Program) Women are considered eligible for high risk screening if they are asymptomatic, are 30-69 years of age and at least one of the following criteria are met: Known carrier of a gene mutation (e.g. BRCA1, BRCA2) First degree relative of a carrier of a gene mutation (e.g. BRCA1, BRCA2), has previously had genetic counselling, and has declined genetic testing Previously assessed as having a 25% lifetime risk of breast cancer on basis of family history4 Received chest radiation (not chest x-ray) before age 30 and at least 8 years previously (e.g. as treatment for Hodgkin’s Lymphoma) CCO Cancer Screening Recommendations and Women at High Risk – Summary of Evidence Not eligible for OBSP (e.g. 30 or 74 years of age) Discuss screening options with health care provider with regards to the benefits and risks of screening Symptomatic or a finding on clinical exam 1 Average risk patients do not require a physician referral for the OBSP. 2 Nurse practitioners can assess patient risk and complete the OBSP requisition for high risk screening, however, a MD colleague (e.g. family physician, GP oncologist, oncologist) needs to sign off on the requisition. The requisition form can be found here OBSP Requisition for High Risk Screening. 3 Women over age 74 can be screened within the OBSP; however, they are encouraged to make a personal decision in consultation with their healthcare provider. The OBSP will not recall women over age 74 to participate in the program. To continue screening throughout the OBSP, a healthcare provider will need to make a referral. 4 A genetic clinic must have used at least one of the following tools to complete this assessment – IBIS 10 Year Risk, IBIS Lifetime Risk, BOADICEA 5 Year Risk or BOADICEA Lifetime Risk. Results must be faxed with requisition form. A Proceed to Page 6 B R2 Proceed to Page 7 C R2 Proceed to Page 8 D Proceed to Page 5

Initial Presentation & Imaging for Symptomatic Patients Breast Cancer Screening & Diagnosis Pathway Map Version 2015.10 Page 5 of 10 The pathway map is intended to be used for informational purposes only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to clinical judgment and actual practice patterns may not follow the proposed steps set out in the pathway map. In the situation where the reader is not a healthcare provider, the reader should always consult a healthcare provider if he/she has any questions regarding the information set out in the pathway map. The information in the pathway map does not create a physician-patient relationship between Cancer Care Ontario (CCO) and the reader. E Persistent suspicious findings Normal 30 years of age and/or breastfeeding or pregnant D From page 4 Patient presents with one or more symptoms of breast cancer, such as: Palpable mass Concerning nipple discharge New nipple retraction Skin changes of the nipple or breast Asymmetric thickening/ nodularity Results Normal assessment Ultrasound Ultrasound Patient’s age Clinical reassessment of symptoms Mammogram Imaging results 30 to 40 years of age Galactography In appropriate clinical contexts Probably benign (BI-RADS 3)5 Short-term imaging follow-up Repeat imaging within 6 months based on radiologist’s recommendations 40 years of age Mammogram Galactography In appropriate clinical contexts 5 The management following the BI-RADS assessment categories are based on the recommendations from the American College of Radiology. For more information see D’Orsi CJ, Sickles EA, Mendelson EB, Morris EA et al. ACR BI-RADS Atlas, Breast Imaging Reporting and Data System. Reston, VA, American College of Radiology; 2013. F Return to Page 4 Results Clinical reassessment of symptoms Suspicious Primary care provider discusses risk appropriate screening7 Normal assessment Suspicious Ultrasound Proceed to page 9 G Proceed to page 9

Average Risk Screening & Assessment Breast Cancer Screening & Diagnosis Pathway Map Version 2015.10 Page 6 of 10 The pathway map is intended to be used for informational purposes only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to clinical judgment and actual practice patterns may not follow the proposed steps set out in the pathway map. In the situation where the reader is not a healthcare provider, the reader should always consult a healthcare provider if he/she has any questions regarding the information set out in the pathway map. The information in the pathway map does not create a physician-patient relationship between Cancer Care Ontario (CCO) and the reader. Normal (e.g. BI-RADS 1 or 2)5 A From Page 4 From Prevention Pathway Map (Page 3) Screening mammogram Every two years or annually if required6 CCO Cancer Screening Recommendations and Screening Ultrasound Position Statement Benign diagnostic assessment (e.g. normal tissue, simple cyst, minimally complicated cyst) Results Normal assessment Diagnostic assessment Abnormal (e.g. BI-RADS 0)5 Diagnostic mammography And/Or Results Probably benign diagnostic assessment (e.g. BI-RADS 3)5 Ultrasound Short-term imaging follow-up Repeat imaging within 6 months based on radiologist’s recommendations Continue imaging followup Results Abnormal assessment H Proceed to page 9 Abnormal diagnostic assessment 5 The management following the BI-RADS assessment categories are based on the recommendations from the American College of Radiology. For more information see D’Orsi CJ, Sickles EA, Mendelson EB, Morris EA et al. ACR BI-RADS Atlas, Breast Imaging Reporting and Data System. Reston, VA, American College of Radiology; 2013. 6 As outlined within the OBSP, annual mammograms may be required for women with one of the following: documented pathology of high-risk lesions (ADH, ALH, LCIS, etc), personal history of ovarian cancer, two or more first degree female relatives with breast cancer at any age, one first degree female relative with breast cancer under age 50 or with ovarian cancer at any age or one first degree male relative with breast cancer at any age. One year recall is recommended if breast density is 75%. For these patients, consider referral to OBSP High Risk Program, if eligible.

Genetic Assessment (Counselling and/or Testing) for Potentially High Risk Patients Breast Cancer Screening & Diagnosis Pathway Map Version 2015.10 Page 7 of 10 The pathway map is intended to be used for informational purposes only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to clinical judgment and actual practice patterns may not follow the proposed steps set out in the pathway map. In the situation where the reader is not a healthcare provider, the reader should always consult a healthcare provider if he/she has any questions regarding the information set out in the pathway map. The information in the pathway map does not create a physician-patient relationship between Cancer Care Ontario (CCO) and the reader. Proceed to Prevention Pathway Map (Page 3) and High Risk Screening (Page 8) Carrier of pathogenic variant in BRCA 1/2 or carrier of other highly penetrant gene (e.g. TP523, CDH1,PTEN, STK11) Eligible B From page 4 Formal assessment of hereditary breast cancer risk OBSP Breast Cancer Genetic Assessment and/or Test Results Genetic testing eligibility Results True negative result for known hereditary gene mutation in family No deleterious mutation identified or variant of undetermined significance Not eligible or patient declines testing Patient declines genetic referral Genetic test OBSP Breast Cancer Genetic Assessment and/or Test Results I Primary care provider discusses risk appropriate screening7 Return to Page 4 25% lifetime risk of breast cancer8 or carrier of mutation in other moderately penetrant gene (e.g. CHEK2, PALB2) Reevaluate patient risk 25% lifetime risk of breast cancer8 Primary care provider discusses risk appropriate screening 7 and discusses health behaviour interventions (e.g. exercise, nutrition) to reduce breast cancer risk as appropriate 7 There is insufficient evidence to recommend appropriate screening guidelines for some risk categories (e.g. a 40 year old woman at increased but not high risk). Risk appropriate screening in these cases is a personalized decision made between the woman and her healthcare provider. Lifetime risk of breast cancer should be based on family history and must have been assessed using IBIS or BOADICEA risk assessment tools, preferably by a genetic or breast cancer clinic. For more information on these tools visit http://www.emstrials.org/riskevaluator/ for IBIS and http://ccge.medschl.cam.ac.uk/boadicea/ for BOADICEA. 8 C Primary care provider discusses risk appropriate screening 7 and discusses health behaviour interventions (e.g. exercise, nutrition) to reduce breast cancer risk as appropriate Proceed to Prevention Pathway Map (Page 3) and High Risk Screening (Page 8) C J Return to Page 4 K Return to Page 4

High Risk Screening Breast Cancer Screening & Diagnosis Pathway Map Version 2015.10 Page 8 of 10 The pathway map is intended to be used for informational purposes only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to clinical judgment and actual practice patterns may not follow the proposed steps set out in the pathway map. In the situation where the reader is not a healthcare provider, the reader should always consult a healthcare provider if he/she has any questions regarding the information set out in the pathway map. The information in the pathway map does not create a physician-patient relationship between Cancer Care Ontario (CCO) and the reader. Normal C From Page 4 or 7 Screening mammogram Screening MRI Screening ultrasound if MRI cannot be preformed To be completed every year. Women ages 70-74 should be screened with mammogram only9. EBS #15-11 and Women at High Risk – Summary of Evidence Normal assessment Results Probably benign (BI-RADS 3)5 Short-term imaging follow-up Repeat imaging within 6 months based on radiologist’s recommendations L Results Abnormal assessment Proceed to Page 9 M From Prevention Pathway Map (Page 3) Abnormal assessment Abnormal Additional imaging (e.g. second look ultrasound, repeat MRI, more mammographic views) Results Probably benign (BI-RADS 3)5 Proceed to Page 9 Short-term imaging follow-up Repeat imaging within 6 months based on radiologist’s recommendations N Abnormal assessment Results Normal assessment 5 The management following the BI-RADS assessment categories are based on the recommendations from the American College of Radiology. For more information see D’Orsi CJ, Sickles EA, Mendelson EB, Morris EA et al. ACR BI-RADS Atlas, Breast Imaging Reporting and Data System. Reston, VA, American College of Radiology; 2013. 9 A screening mammogram and MRI should be completed within 30 days of each other. Normal assessment Proceed to Page 9

Diagnostic Procedures Breast Cancer Screening & Diagnosis Pathway Map Version 2015.10 Page 9 of 10 The pathway map is intended to be used for informational purposes only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to clinical judgment and actual practice patterns may not follow the proposed steps set out in the pathway map. In the situation where the reader is not a healthcare provider, the reader should always consult a healthcare provider if he/she has any questions regarding the information set out in the pathway map. The information in the pathway map does not create a physician-patient relationship between Cancer Care Ontario (CCO) and the reader. Consider shortterm imaging follow-up or return to risk-appropriate screening Concordant G H L M N From Benign MRI suspicious lesion10 Only for high-risk patients Concordance with pathology, imaging and clinical examination Core biopsy Vacuum assisted with clip placement Discordant O R Surgeon Second core needle biopsy or vacuum biopsy pages 5, 6 or 8 From Follow-up Care Pathway Map (Page 4) Pathology Concordant P Return to Page 4 Results Discordant -Ultrasound suspicious mass, complex cyst11, intraductal nodule11, concerning calcifications -Suspicious mammographic finding Pathology12 Results Core biopsy Fine needle aspiration Lymph nodes Indeterminate or concerning High risk/concerning benign (e.g. Atypical ductal hyperplasia, radial scars, papilloma) R Ductal Carcinoma In Situ Proceed to Treatment Pathway Map (Page 3) Invasive Breast Cancer Proceed to Treatment Pathway Map (Page 5) Or R Surgeon Insufficient tissue sampling Suspicious clinical finding woman and her healthcare provider. 11 An excisional biopsy may be considered for presumed isolated papillary lesions in the appropriate clinical context. 12 Biomarkers should be performed on core biopsies showing invasive cancer. Surgeon Surgeon Proceed to Page 10 R R Second core biopsy 7 There is insufficient evidence to recommend appropriate screening guidelines for some risk categories (e.g. a 40 year old woman at increased but not high risk). Risk appropriate screening in these cases is a personalized decision made between the 10 In rare circumstances a breast MRI may be used as a problem solving tool Q Proceed to Page 10 Cancer Core biopsy E From Page 5 Proceed to Page 10 Primary care provider discusses risk appropriate screening or shortterm imaging followup7

Diagnostic Procedures (contd) Breast Cancer Screening & Diagnosis Pathway Map Version 2015.10 Page 10 of 10 The pathway map is intended to be used for informational purposes only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to clinical judgment and actual practice patterns may not follow the proposed steps set out in the pathway map. In the situation where the reader is not a healthcare provider, the reader should always consult a healthcare provider if he/she has any questions regarding the information set out in the pathway map. The information in the pathway map does not create a physician-patient relationship between Cancer Care Ontario (CCO) and the reader. Benign Excisional biopsy O Q R From page 9 Pathology12 Results Primary care provider discusses risk appropriate screening7 Ductal Carcinoma In Situ Proceed to Treatment Pathway Map (Page 3) Invasive Breast Cancer Proceed to Treatment Pathway Map (Page 5) Cancer Return to riskappropriate screening 7 There is insufficient evidence to recommend appropriate screening guidelines for some risk categories (e.g. a 40 year old woman at increased but not high risk). Risk appropriate screening in these cases is a personalized decision made between the woman and her healthcare provider. 12 Biomarkers should be performed on core biopsies showing invasive cancer. Return to Page 4 Proceed to Prevention Pathway Map Confirmed high risk benign Or Short-term imaging follow-up Repeat imaging within 6 months based on radiologist’s recommendations S

Breast Cancer Screening & Diagnosis Pathway Map Pathway Glossary Version 2015.10 Page 3 of 10 The pathway map is intended to be used for informational purpos es only. The pathway map is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. Further, all pathway maps are subject to .

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