Preface
This document was drafted in accordance with the provisions of GB/T 1.1-2020 “Guidelines for standardization work Part 1: Structure and drafting rules for standardized documents”.
This document was proposed by the National Cancer Center.
This document is attributed by the Chinese Society of Preventive Medicine.
This document is drafted by: National Cancer Center, Nanjing Medical University, Cancer Hospital of Tianjin Medical University, Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Hospital, Lanzhou University, China Medical University, Hunan Cancer Hospital, Fourth Hospital of Hebei Medical University, Cancer Hospital of Henan Province, Sichuan Cancer Hospital.
Main drafters of this document: He Jie, Shen Hongbing, Chen Wanqing, Chen Kexin, Zhou Baosen, Li Ni, Hu Zhibin, Wang Yong, Li Jing, Wang Xiang, Wang Jing, Ma Fei, Li Jiang, Tian Jinhui, He Yutong, Yan Shipeng, Sun Xibin, Li Bo.
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In 2015, female breast cancer ranked first in the spectrum of cancer incidence and fifth in the spectrum of cancer deaths among women in China’s tumor registry areas. Improving the detection rate of early breast cancer and its precancerous lesions and providing timely and effective treatment are important measures to improve breast cancer prognosis and reduce breast cancer mortality. The Chinese government has launched several major national public health service programs, including breast cancer screening, such as the urban cancer early diagnosis and treatment program and the national screening program for rural women for “two cancers”, which have achieved remarkable results. However, most of the high-quality studies in the current screening guideline evidence come from Western countries. Since the physiological characteristics of women’s breasts and the prevalence of breast cancer in China are quite different from those in western countries, foreign experiences cannot be copied. Therefore, there is an urgent need to establish breast cancer screening standards in China, standardize cancer screening and early diagnosis and treatment techniques, improve the scientificity, feasibility and applicability of cancer screening, reduce the cost of cancer treatment, enhance social and economic benefits, and improve the homogenization and homogenization of cancer screening services.
Breast Cancer Screening Standards for Chinese Women
1 Scope
This document specifies the basic principles of the screening population, screening measures, screening requirements, screening result management and follow-up process, screening organization management requirements, screening quality control and resource base establishment and management in the process of breast cancer screening.
This document applies to breast cancer screening in medical institutions at all levels nationwide.
2 Normative References
The content of the following documents constitutes the essential provisions of this document through the normative references in the text. Among them, the reference document with the date, only the version corresponding to the date is applicable to this document; the reference document without the date, its latest version (including all the revision sheets) is applicable to this document.
GB/T 37864-2019 General requirements for the quality and capacity of biological sample repositories
T/CPMA 002-2019 Technical specifications for long-term follow-up of endpoint events in large population cohorts
T/CPMA 001-2018 Technical Specification for Data Processing of Large Population Cohort Studies
3 Abbreviations
BI-RADS: Breast Imaging Reporting and Data System (BIRDS)
DICOM: Digital Imaging and Communications in Medicine (DICOM)
4 Screening Populations
4.1 Screening for breast cancer should be performed in the general risk population between the ages of 45 and 70 years. Women at average risk for breast cancer are all women of appropriate age except for those at high risk for breast cancer (see 4.2 for definition).
4.2 Screening for breast cancer is recommended for high-risk groups starting at age 40. Women who meet any of the following conditions a), b) and c) are at high risk for breast cancer
a) Have a genetic family history, i.e., have any of the following.
1) A history of breast or ovarian cancer in a first-degree relative
2) 2 or more second-degree relatives with breast cancer before the age of 50
3) 2 or more second-degree relatives with ovarian cancer before the age of 50
4) At least one first-degree relative carries a known pathogenic genetic mutation in the BRCA1/2 gene; or carries a pathogenic genetic mutation in the BRCA1/2 gene.
b) Have any one of the following.
1) Age at menarche is not older than 12 years.
2) Age of menopause not less than 55 years.
3) History of breast biopsy or surgery for benign breast disease, or pathologically confirmed atypical hyperplasia of the breast (lobules or ducts).
4) Hormone replacement therapy with “combined estrogen and progestin” for not less than six months.
5) Mammogram after 45 years of age indicating heterogeneous dense or dense breast parenchyma (or breast density) type.
c) Any two of the following.
1) No history of breastfeeding or breastfeeding for less than 4 months
2) No history of live birth (including never-born, miscarriage, stillbirth) or age of first live birth not less than 30 years.
3) Hormone replacement therapy with “estrogen” only for at least six months.
4) Miscarriage (including spontaneous and induced abortions) not less than 2 times.
Note 1: First degree relatives refer to mother, daughter and sister.
Note 2: Second-degree relatives refer to aunts, uncles, grandmothers, and maternal grandmothers.
5 Screening measures
5.1 General risk population
Screening measures for the general risk population are
a) Breast ultrasound should be performed every 1 to 2 years.
b) If mammography is not available, mammography is appropriate.
5.2 High-risk groups
Screening measures for high-risk groups are
a) Breast ultrasound combined with mammography should be performed once a year.
b) For areas where mammography is not available, breast ultrasound is appropriate.
c) For those tested as BRCA1/2 mutation carriers, it is advisable to use breast ultrasound combined with mammography followed by breast MRI.
6 Screening examination requirements and classification of results
6.1 Screening test requirements
Screening instruments and operational requirements should be in accordance with Appendix A.
6.2 Classification of diagnostic results
6.2.1 Mammography diagnostic result classification
Mammography diagnostic basis is appropriate to record and analyze the diagnostic imaging results in accordance with Appendix B. The results of the diagnostic basis should be evaluated and classified according to the following provisions.
a) BI-RADS 0: existing images fail to complete the evaluation and require the addition of other imaging examinations, including pressure point films, pressure magnification, additional shots of other body positions, or the performance of ultrasonography.
b) BI-RADS 1: normal, with no abnormal findings on mammography. 0% likelihood of malignancy.
c) BI-RADS 2: benign findings, presence of definite benign changes, no signs of malignancy. 0% probability of malignancy.
d) BI-RADS 3: lesions with a high probability of benignity. Malignant likelihood greater than 0% but not greater than 2%.
e) BI-RADS 4: lesions of suspected malignancy but without typical signs of malignancy. Malignant likelihood greater than 2% but less than 95%.
1) BI-RADS 4A: low suspicion of malignancy with a likelihood of malignancy greater than 2% but not greater than 10%.
2) BI-RADS 4B: moderate suspicion of malignancy with a likelihood of malignancy greater than 10% but not greater than 50%.
3) BI-RADS 4C: Highly suspected malignancy, with a malignant probability greater than 50% but less than 95%.
f) BI-RADS 5: lesions highly suggestive of malignancy, with typical imaging features of breast cancer and a malignancy likelihood of not less than 95%.
Note: Appendix B shows the adoption of the Breast Imaging Reporting and Data System (BI-RADS) developed by the American College of Radiology (ACR) and widely adopted internationally for recording and analyzing diagnostic imaging results.
6.2.2 Classification of Diagnostic Breast Ultrasound Results
Breast ultrasound diagnostic basis is appropriate to record and analyze diagnostic imaging results according to Appendix B, and the resultant diagnostic basis should be evaluated and classified according to the following provisions.
a) BI-RADS 0: the diagnostic information obtained by ultrasound is incomplete and cannot be evaluated, and the patient needs to be recalled and advised to undergo other imaging examinations such as breast MRI and mammogram before evaluation.
b) BI-RADS 1: Negative, no abnormal findings on ultrasound. 0% probability of malignancy.
c) BI-RADS 2: benign lesion with definite benign changes and no signs of malignancy. 0% probability of malignancy.
d) BI-RADS 3: Benign lesion with a high probability of benignity. Malignant likelihood greater than 0% but not greater than 2%.
e) BI-RADS 4: lesions of suspected malignancy but without typical signs of malignancy. Malignant likelihood greater than 2% but less than 95%.
1) BI-RADS 4A: low suspicion of malignancy with a likelihood of malignancy greater than 2% but not greater than 10%.
2) BI-RADS 4B: moderate suspicion of malignancy with a likelihood of malignancy greater than 10% but not greater than 50%.
3) BI-RADS 4C: Highly suspected malignancy, with a malignant probability greater than 50% but less than 95%.
f) BI-RADS 5: a lesion highly suggestive of malignancy with typical imaging features of breast cancer. The likelihood of malignancy is not less than 95%.
Note: Appendix B ultrasound assessment classification refers to the BI-RADS classification criteria proposed by the National Comprehensive Cancer Network (NCCN) screening and the American College of Radiology (ACR).
7 Outcomes Management and Follow-up Process
7.1 Outcome Management
Screening results are managed according to the following.
a) BI-RADS 1 and BI-RADS 2: no special handling required.
b) BI-RADS 3: Mammographic evaluation for BI-RADS 3, mammographic review of the breast on the side of the lesion is appropriate at 6 months thereafter and bilateral mammography review at months 12 & 24. If the lesion remains stable, the review can be continued; if there is no change at the 2- to 3-year follow-up, it can be downgraded to BI-RADS 2. If the lesion disappears or shrinks during the review, it can be assessed directly as BI-RADS 2 or BI-RADS 1. If there are suspicious findings during the review, biopsy should be considered. (b) Breast ultrasound assessed as BI-RADS 3, it is advisable to perform breast ultrasound review in 3 months to 6 months, and those with no change during the 2-year follow-up may be downgraded to BI-RADS 2.
c) BI-RADS 4A: further imaging and, if necessary, biopsy should be performed.
d) BI-RADS 4B: further imaging should be performed and biopsy is appropriate.
e) BI-RADS 4C and BI-RADS 5: Biopsy should be performed.
7.2 Follow up process
Follow-up visits should be in accordance with the following provisions.
a) For subjects with screening results of BI-RADS 4 and BI-RADS 5, follow-up visits shall be conducted by telephone, home visits and medical institution case information retrieval and access to obtain information on the final diagnosis and outcome of each screening subject.
b) See Chapter 9 for follow-up quality control indicators.
8 Screening Organization and Management Requirements
8.1 Screening flow chart (see Appendix C)
8.2 Procedure for Informed Consent
8.2.1 All screening participants sign an informed consent form on a voluntary basis. Before signing the informed consent, the intended participant needs to be informed about the screening and have questions answered.
8.2.2 The content of the informed consent form should include at least
a) The purpose of the screening.
b) the significance of the screening.
c) the screening process.
d) the possible benefits and risks of participating in the screening.
e) the cost of the screening.
f) the principles of confidentiality and voluntariness
g) Signature and date.
8.3 Risk assessment site and staff requirements
8.3.1 Screening for breast cancer should begin with a risk assessment of the population through an epidemiological questionnaire. The content of the questionnaire should be as listed in Appendix D.
8.3.2 Risk assessment can be conducted in medical institutions; self-assessment services can also be provided to residents through information technology, with necessary consultation and answers by medical institution staff.
8.3.3 Personnel responsible for risk assessment should receive training on breast cancer screening-related expertise organized by authoritative institutions before taking up the job.
8.4 Screening medical institutions and staff requirements
8.4.1 Requirements for medical institutions undertaking breast cancer screening
a) Have the ability to screen, diagnose and/or treat breast cancer.
b) Breast ultrasound and mammography instruments meet the screening requirements and are regularly maintained and calibrated by dedicated personnel.
8.4.2 Screening Staff Requirements
Screening staff should be multidisciplinary and should include physicians and staff from epidemiology, imaging, breast surgery, oncology, laboratory and pathology, and other screening-related disciplines; at the same time, staff should be available to follow up the results of the follow-up review of screening subjects and to enter the information into the computer database and archive.
8.4.3 Screening diagnosis and operation staff requirements
Diagnostic and operational staff should meet the following requirements.
a) Diagnostic breast ultrasound physician: initial screening should be performed by an attending physician (more than 3 years) who has worked in the ultrasound specialty for more than 5 years or who is senior in rank (more than 3 years); if positive cases are encountered, they should be reviewed by a physician with the title of associate senior or above.
b) Mammography operator technician.
1) having undergone professional technical training and obtained an induction certificate as a mammography operating technologist (issued by the national or local health and wellness committee)
2) have more than 2 years of mammography experience, fixed in mammography workers preferred.
c) Diagnostic mammography physician.
1) More than 5 years of experience in diagnostic mammography.
2) In case of dual-reading diagnostic mode, one of them should be an attending physician with the title of associate senior or above or working full-time for more than 3 years.
8.5 Screening equipment requirements
Screening equipment should meet the following requirements.
a) mammography: mammography machine (medical license calibration pass), see Appendix A.
b) breast ultrasound: with color ultrasound diagnostic instrument (high-frequency line array probe), see Appendix A.
9 Quality Control
Screening quality control should be in accordance with the following.
a) Staff in risk assessment, screening diagnostics, and results management should have the required job qualifications and work background.
b) Regular review of 100% of screened breast cancer BI-RADS 4 or higher images by physicians of associate senior level or above in imaging and 1% sampling for others.
c) Mammography equipment, should be tested annually by a department qualified to test medical equipment according to industry standards for status and obtain a certificate of compliance.
d) hard copy imaging cameras, automatic film washers, sensitization screens, film and digital image soft reading and reading environment, should be quality managed according to equipment quality assessment procedures.
e) Quality control of follow-up visits should refer to Part VII “Quality Control and Evaluation” of T/CPMA 002-2019.
10 Breast Cancer Screening Resource Library Establishment and Management
Where available, it is appropriate to establish a breast cancer screening resource bank, which should include a screening database, an imaging database, and a biospecimen bank. It is appropriate to establish the following requirements.
a) The screening database should include risk assessment data, breast cancer screening data, clinical diagnosis and treatment data, and follow-up data. The type of data and privacy protection should refer to Part IV of T/CPMA 001-2018, “Privacy Protection of Data from Large Cohort Studies”.
b) Images from breast ultrasound and/or mammography should be included, with all images available in DICOM and JPG formats for breast ultrasound and a total of 4 images in DICOM format for mammography on both sides.
c) For those participating in screening, it is appropriate to collect and store blood samples; for BI-RADS 4 and 5 requiring biopsy, biopsy should be performed at a medical facility with biopsy facilities and storage of tissue samples, etc. The collection, transportation and storage of biological samples are appropriate with reference to the requirements in GB/T 37864-2019.
Appendix A
(prescriptive)
Screening Instruments and Operating Requirements
A.1 Mammography
A.1.1 Mammography machine (medical license verification qualified)
a) Mammography: digital acquisition imaging system (50 micron pixel CR/DR) + laser printing system for mammography.
b) adjustable brightness, high-brightness viewing lights with amplitude masking device (maximum brightness not less than 3000cd/m2), CR/DR soft reading/3-5M vertical screen.
c) Imaging quality testing related breast modalities.
A.1.2 Operational requirements
A.1.2.1 Pre-irradiation preparation
The steps involved in the irradiation process should be carefully explained to the examinee before irradiation and the examinee should be asked to cooperate.
A.1.2.2 Irradiation position
The conventional irradiation positions are mediolateral oblique (MLO) and craniocaudal (CC), and the MLO and CC films should conform to the following
a) The MLO view shows the breast pushed anteriorly upward, the breast parenchyma fully expanded, the pectoralis major muscle visible and more relaxed, the lower edge reaching the level of the nipple, the nipple in the tangential position, part of the abdominal wall included in the slice but separated from the lower breast, and the vast majority of the breast parenchyma shown in the slice.
b) A CC-position film shows the breast in the center of the slice, the nipple in the tangential position, a small portion of the pectoralis major muscle is visible and should encompass the entire inner quadrant, with most of the lateral breast tissue shown and possibly a small portion not included in the image.
A.1.2.3 Additional projection positions and projection techniques
For breast parenchyma that is poorly displayed or not fully encompassed in the MLO and CC positions, the following can be selected depending on the location of the lesion: lateromedial (LM), medialolateral (ML), medial craniocaudal (MCC), lateral craniocaudal (LCC) craniocaudal (LCC) position and cleavage position. Further special photographic techniques may be used to evaluate abnormal changes shown in the above conventional photography. Localized compression photography, magnification, or localized compression magnification may be performed at any projection site to further visualize the lesion and clarify the nature of the lesion.
A.2 Ultrasound of the breast
A.2.1 Equipment requirements
A.2.1.1 A color ultrasound diagnostic instrument (high-frequency line array probe) with a probe frequency of (7.5~12.0) MHz, or 15.0 MHz when available, but for thick breast tissue or prosthesis, the probe frequency can be reduced appropriately.
A.2.1.2 The principle of choosing the ultrasound probe and frequency is to increase the frequency as much as possible to ensure the resolution of the ultrasound image under the premise of ensuring sufficient probing depth.
A.2.2 Operation requirements
The operation requirements are as follows.
a) Inspection part and mode
1) During the examination, the affected arm is lifted and abducted as much as possible to fully expose the breast and axilla, and the probe is placed directly on the surface of the breast, and the nipple, areola and four quadrants of the external upper, external lower, internal upper and internal lower breast are scanned comprehensively, the order of which can be determined by the operator.
2) The scanning mode includes radial, antiradial, rotational and parallel movement, which can be selected according to the habit of the examinee. The scope of examination should be comprehensive and should not be missed, and the axillary lymph nodes should be checked at the same time.
b) Examination content and measurement method
1) The examination should begin with a comprehensive routine 2D ultrasound examination of the breast and surrounding tissues, followed by a focused 2D ultrasound examination of the area where the lesion is found. The examination should include: determination of the location, size or extent of the lesion, boundary, margin, shape, internal and posterior echogenicity, calcification and changes in surrounding tissues including skin, pectoral muscle and ligaments. The measurement of the size or extent of the lesion should be made by selecting its largest plane, measuring the two longest diameter lines perpendicular to each other, and then measuring a third diameter line in the largest plane perpendicular to this cut.
2) When measuring, the cursor should be placed on the outer side of the edge of the lesion and measured according to the boundary when the boundary of the lesion is clear, and when the boundary of the mass is blurred, it should be measured according to the largest edge portion of the mass or the surrounding acoustic corona. Color and energy Doppler ultrasonography should be supplemented with two-dimensional sonography to observe the course and distribution of colored blood flow and to measure various blood flow parameters on the Doppler spectrum. When available, three-dimensional reconstruction imaging, elastography and contrast-enhanced contrast imaging can be used to observe the hardness changes, spatial relationships and vascular distribution of the lesion and breast tissue, and to understand the texture changes and blood perfusion of the lesion and tissue.
Appendix B
(informative)
Diagnostic Imaging Rationale
B.1 Definitions related to diagnostic imaging of the breast
B.1.1 Breast parenchyma (or breast density) type
Breast parenchyma types are classified as
a) fatty type.
b) scattered fibrous glandular type.
c) inhomogeneous dense type (may obscure small lumps).
d) dense (reduces the sensitivity of breast cancer detection).
B.1.2 Abnormal Signs
Abnormal signs include masses, calcifications, structural distortions, asymmetry, intramammary lymph nodes, skin lesions, unilateral dilated ducts, and concomitant signs.
B.1.2.1 Masses
A mass is an occupying lesion visible in two different projection positions and is described as follows
a) Shape: round, ovoid, irregular.
b) Margins.
1) Clear: at least 75% of the mass borders are clearly and sharply demarcated from the surrounding normal tissue; the remaining portion of the margins may be obscured by surrounding glands but without signs of infiltration or burr. If any mass with infiltration or burr at the margin should be judged as 4) or 5) below
2) obscured: the mass is obscured by overlapping or adjacent normal tissues and no further judgment can be made on it; the reviewing physician believes that this mass has clear borders and is only obscured by the surrounding glands.
3) microlobulation: small wavy changes in the margins.
4) infiltration: irregularity of the border caused by infiltration of the lesion itself into the surrounding area, rather than due to obscuration by surrounding glands
5) burr: radiolucent line shadow emanating from the edge of the mass.
c) Density: compared to the same volume of breast tissue surrounding the mass, it can be classified as high density, isointensity, hypointensity (without fat), and fat-containing density.
B.1.2.2 Calcification
The morphology and distribution of calcifications are described as
a) Morphology.
1) Typical benign calcifications: including: cutaneous calcifications, vascular calcifications, coarse or popcorn-like calcifications, large rod-shaped calcifications, round calcifications, ring-shaped calcifications, dystrophic calcifications, calcifications of calcium breast and suture calcifications.
2) Suspicious morphologic calcifications: including indefinite or indistinct calcifications, coarse inhomogeneous calcifications, fine polymorphic calcifications (often less than 0.5 mm in diameter), and fine-wire-like or fine-wire branch-like calcifications; the latter often suggest intra-ductal luminal calcifications invaded by breast cancer.
b) The distribution of typical benign calcifications need not be described; the distribution of suspicious calcifications is described as
1) diffuse distribution.
2) Regional distribution: calcifications distributed over a larger area, not conforming to the ductal distribution, often larger than 2 cm2; the nature of this calcification distribution should be considered in conjunction with the morphology.
3) Cluster distribution: calcifications with at least 5 calcifications occupying a smaller area (less than 1cm2), with more calcifications clustered in piles, in the range of 2cm2.
4) linear-like distribution: calcifications arranged in a linear pattern and located within the duct.
5) Segment-like distribution: originating from one duct and its branches.
B.1.2.3 Structural distortion
Normal structures are distorted but no clear mass is visible, including radiolucent shadowing and focal constriction emanating from a single point, or distortion at the edges of the parenchyma.
B.1.2.4 Asymmetry
Signs of asymmetry are described according to the following.
a) Structural asymmetry: fibroglandular tissue visible in only one projection location, mostly due to overlap of normal glandular tissue.
b) Overall asymmetry: asymmetry of a larger area of glands, up to at least 1 quadrant, not accompanied by other signs, mostly normal variants. However, it may be significant when coinciding with clinically palpable abnormalities.
c) Focal asymmetry: both projection locations show and behave similarly, but lack the characteristic convex marginal changes of a true mass, are often concave, and are less extensive than spherical asymmetry. It may represent an island of normal glands (especially if it contains fat). However, in the absence of characteristic benign signs, it often requires further examination, which may reveal a true mass or significant structural distortion changes.
d) Progressive asymmetry: a new, enlarged or more pronounced focal asymmetry than before.
B.1.2.5 Intramammary lymph nodes
Intramammary lymph nodes typically present as kidney-shaped, translucent cuts due to fat in the lymph node portal visible to the naked eye, often less than 1 cm. when the lymph nodes are large, but most of them are replaced by fat, they are still benign changes. It can be multiple, or one lymph node may look like multiple round nodal shadows due to significant fat replacement. A correct diagnosis can be made for characteristic changes in the upper outer part of the breast. Occasionally, they can be found in other areas, mostly in association with veins.
B.1.2.6 Cutaneous lesions
Skin lesions projected within the breast tissue, especially when shown in both projection positions, should be mentioned in the evaluation report. The technician taking the film should place an x-ray-opaque marker at the skin lesion.
B.1.2.7 Unilaterally dilated ducts
Tubular or branch-like structures may represent dilated or thickened ducts.
B.1.2.8 Associated concomitant signs
B.1.3 Site of lesion
The lesion is described as
a) Location: indicate left and/or right side.
b) Quadrant and clock face indication: external superior quadrant, internal superior quadrant, external inferior quadrant, internal inferior quadrant, subareolar, central, and axillary caudal.
c) Depth: from the nipple backwards, describe the depth in terms of the anterior, middle and posterior 1/3.
d) Note the distance of the lesion from the nipple.
B.2 Mammography diagnostic evaluation classification
The diagnostic assessment classification of mammography should be in accordance with the provisions of Table B.1.
Table B.1 Diagnostic assessment classification of mammography
Note: The expression “-” is not applicable and “X” indicates the possibility of malignancy.
B.3 Classification of diagnostic evaluation of breast ultrasound
The classification of diagnostic evaluation of breast ultrasound should be in accordance with Table B.2.
Table B.2 Diagnostic evaluation classification of breast ultrasound
| Categories | Description | Possibility of malignancy |
| BI-RADS 0 | Diagnostic information obtained by ultrasound is incomplete and cannot be evaluated, and the patient needs to be recalled and advised to undergo other imaging studies such as breast MRI, mammogram before evaluation | – |
| BI-RADS 1 | Negative, no abnormal findings on ultrasound, i.e. breast ultrasound shows clear breast structure, no lumps, no skin thickening, no microcalcifications, etc. (If intramamammary lymph nodes or anterior axillary lymph nodes are found, but the lymph nodes have no abnormal morphology and show lymphatic portals. All are considered normal lymph nodes and also belong to category 1) | 0% |
| BI-RADS 2 | Benign lesions, including benign breast masses (simple cysts, cumulus cysts, fibroadenomas, fibrolipid adenomas, lipomas with no change after follow-up), definite benign calcifications, breast prosthesis implants, etc. | 0% |
| BI-RADS 3 | Benign possibilities are high. Newly discovered fibroadenoma, cystic adenopathy, verrucous hyperplastic nodules (in the indeterminate category), unsuspected multiple complex cysts or cluster cysts, pathologically definite inflammatory breast disease and early postoperative follow-up of malignant lesions can be classified in this category Short-term follow-up (every 3-6 months) is recommended for category 3, and those with no change at 2-year follow-up can be downgraded to category 2 |
0%<X≤2% |
| BI-RADS 4 | Suspicious malignancy. Pathological examination (e.g. fine needle aspiration cytology, puncture tissue biopsy, surgical biopsy) is recommended to clarify the diagnosis | 2%<X<95% |
| BI-RADS 4A | Low grade suspicious malignancy. Pathology report results are usually non-malignant and should be followed up for 6 months or routinely after obtaining benign biopsy or cytology results. For example, a palpable, locally well-defined, substantial mass with ultrasound features suggestive of a fibroadenoma; a complex palpable cyst or possible abscess | 2%<X≤10% |
| BI-RADS 4B | Moderate suspicion of malignancy. Lesions belonging to this grading have closely related radiology and pathology. Partly well-defined and partly ill-defined fibroadenomas or fat necrosis can be followed, but papillomas may require excisional biopsy | 10%<X≤50% |
| BI-RADS 4C | Highly suspicious for malignancy, but not grade 5 typical malignancy. Examples include irregular parenchymal masses with poorly defined borders or new clusters of fine polymorphic calcifications. A lesion of this grade would likely be a result of malignancy | 50%<X<95% |
| BI-RADS 5 | Highly suggestive of malignant lesions with imaging features typical of breast cancer including burrs, angularity (serration), branching forms (crab feet), microlobules, microcalcifications, thick-walled acoustic halos, aspect ratios greater than 1, and posterior field attenuation. category 5 is recommended in Biopsy first without contraindications, such as puncture biopsy or surgical excisional biopsy, followed by clinical management | X≥95% |
Note: The “-” expression is not applicable and “X” indicates the likelihood of malignancy.
Appendix C
(informative)
Breast Cancer Screening Process
The breast cancer screening process is given in Figure C.1.
Figure C.1 Breast cancer screening flowchart
C
D
APPENDIX D
(Informative)
Breast Cancer Risk Assessment Questionnaire
The following is the referenceable content of the breast cancer risk assessment.
Name: __________
Date of birth: _______ ______ _______ (please fill in the solar birthday)
Place of origin: ________ province ______ city _______ county (district)
Ethnicity: 1. Han Chinese 2. Mongolian 3. Hui 4. Manchu 5. Zhuang < strong>6. Uyghur 7. Kazakh 8. Other, please specify ________
ID number: ________________________________
Personal contact number: __________________________ (mobile); __________________________ (landline)
Contact person1 Phone: __________________________ (mobile)Contact person2< strong>Phone: __________________________ (mobile)
Permanent address: ______________________________ Workplace: ______________________________
| 1. Physical and reproductive profile |
| 1.1 What was your age at first menstruation (weeks)? |
| 1.5 Do you have a history of breastfeeding? 0. No 1. Yes |
| 2.3 Have you ever had a mammogram that showed a type of breast parenchyma (or breast density) that was inhomogeneously dense or dense 0. No 1. Yes |
| 3. Family history of breast cancer |