Screening Breast US Fllw-up Assessment Frm N. Instructins: The frm is cmpleted at 12, 24 and 36 mnths pst initial n study mammgraphy and ultrasund by the Radilgist r RA. Reprt all interim infrmatin related t the time perid, e.g. imaging, bipsy, surgery and/r nn-prtcl related treatment. The frm is cmpleted whether r nt there was any activity and is designed primarily t capture imaging and bipsy events at facilities ther than the study imaging site. Include nly items that have nt previusly been reprted. NOTE: Fr a "6-mnth" fllw-up (perfrmed at study site) after any annual exam, cmplete frm F6 instead f, fr additinal views use IM, fr cre bipsies use BX, etc. 1. Time pint f this fllw-up 12 mnths 24 mnths 36 mnths 1a. Recrd actual elapsed mnths since study entry 2. Date f fllw-up cntact r attempt - - 3. Methd f cntact At appintment By telephne 4. Participant Status Alive (prceed t Q5) Dead (cmplete Q4a) Lst t fllw-up; unable t cntact (prceed t Q4b) 4a. Date f death - - If date f death unknwn cde 12-12-2100 If exact date is unknwn, chse the 15th f that mnth. 4b. Date f last cntact - - Sectin I. Clinical Status 5. Was a clinical breast exam f the breast(s) perfrmed since the last annual screening visit? N (prvide reasn in Q5a) Yes (cmplete then prceed t Q5b and Q5c) Right (cmplete Qs 5b and 5c) Left (cmplete Qs 5b and 5d) Bth (cmplete Qs 5b-5d) Unknwn (prceed t Q6) 5a. Prvide reasn CBE nt dne (then prceed t Q6): Patient missed appintment Patient unable t be lcated Patient pregnant r lactating Patient refused Referring physician's chice Expired 5b. Date f fllw-up CBE - mm Fr revised r crrected frm:check bx and fax t 215-717-0936. yyyy 5c. Have there been any clinically significant changes in the right breast since the last annual examinatin? N r breast nt n study Yes (check all clinical changes that apply) Palpable mass (cmplete lcatin) Lcatin f abnrmality 'clck r specify lcatin: Axilla Retrarelar Unknwn Nipple discharge (detail): Bldy Clear spntaneus Other Other, specify: 5d. Have there been any clinically significant changes in the left breast since the last annual examinatin? N r breast nt n study Yes (check all clinical changes that apply) Palpable mass (cmplete lcatin) Lcatin f abnrmality 'clck r specify lcatin: Axilla Retrarelar Unknwn Nipple discharge (detail): Bldy Clear spntaneus Other Other, specify: 6. Current use f hrmnes? N (prceed t Q7) Yes (cmplete Q6a) 6a. Specify hrmne(s) 7. Has any interval breast imaging been perfrmed since last visit? (cnsider nly items nt previusly reprted n frms IM, F6, etc., per instructins.) N (prceed t Sectin III) Yes (cmplete Q7a) 7a. Check all breast imaging perfrmed since last visit: Mammgram (cmplete Q8) Ultrasund (cmplete Q11) MRI (cmplete Q14) Other (cmplete Q17) D nt recall details (prceed t Q20) "Cpyright 2005" 6666 02-28-05 1 f 5
Fr revised r crrected frm, check bx and fax t 215-717-0936. Sectin II. Interval Imaging N. 8. Mammgram (If n mammgram perfrmed prceed t Q11) Identify the study breast(s) n which a mammgram was perfrmed in the past 11 mnths. NOTE: Interval mammgraphy at study site shuld be reprted n frms IM and/r F6 as apprpriate. Right (Cmplete Qs 8a, 8b and 9) Left (Cmplete Qs 8a, 8b and 10) Bth (Cmplete Qs 8a-10a) 8a. Date f mst recent mammgram - mm yyyy 8b. Specify basis fr decisin t btain the Mammgram Recmmended by: MD wh referred yu fr screening Anther physician (identify type f physician) Surgen Other r unknwn Smene else (specify relatinship f this persn t yu) 9. Mammgraphic Assessment f Right Breast If N evaluatin f Right Breast perfrmed, prceed t Q10 If utside study cdes "4, suspicius", cde as 4B. 9a. Reprted Assessment fr right breast 1 Negative 2 Benign 3 Prbably Benign 4A Lw Suspicin f Malignancy 4B Intermediate Suspicin 4C Mderately High Suspicin 5 Highly Suggestive f Malignancy Assessment unknwn r incmplete (unable t btain reprted assessment, dne at anther imaging facility, BIRADS 0, r partial reprt) 10. Mammgraphic Assessment f Left Breast If N evaluatin f Left Breast perfrmed, prceed t Q11 If utside study cdes "4, suspicius", cde as 4B 10a. Reprted Assessment fr left breast 1 Negative 2 Benign 3 Prbably Benign 4A Lw Suspicin f Malignancy 4B Intermediate Suspicin 4C Mderately High Suspicin 5 Highly Suggestive f Malignancy Assessment unknwn r incmplete (unable t btain reprted assessment, dne at anther imaging facility, BIRADS 0, r partial reprt) 11. Ultrasund (If n ultrasund perfrmed prceed t Q14) Identify the study breast(s) n which an Ultrasund was perfrmed in the past 11 mnths. NOTE: Interval ultrasund at study site shuld be reprted n frms IM and/r F6 as apprpriate. Right (Cmplete Qs 11a, 11b and 12) Left (Cmplete Qs 11a, 11b and 13) Bth (Cmplete Qs 11a-13a) 11a. Date f mst recent ultrasund - 11b. Specify basis fr decisin t btain the Ultrasund Recmmended by: MD wh referred yu fr screening Anther physician (identify type f physician) Surgen Other r unknwn Smene else (specify relatinship f this persn t yu) 12. Ultrasund Assessment f Right Breast If N evaluatin f Right Breast perfrmed, prceed t Q13 If utside study cdes "4, suspicius", cde as 4B 12a. Assessment fr right breast 1 Negative 2 Benign 3 Prbably Benign 4A Lw Suspicin f Malignancy 4B Intermediate Suspicin 4C Mderately High Suspicin 5 Highly Suggestive f Malignancy Assessment unknwn r incmplete (unable t btain reprted assessment, dne at anther imaging facility, BIRADS 0, r partial reprt) 13. Ultrasund Assessment f Left Breast If N evaluatin f Left Breast perfrmed, prceed t Q14 If utside study cdes "4, suspicius", cde as 4B 13a. Assessment fr left breast 1 Negative 2 Benign 3 Prbably Benign 4A Lw Suspicin f Malignancy 4B Intermediate Suspicin 4C Mderately High Suspicin 5 Highly Suggestive f Malignancy Assessment unknwn r incmplete (unable t btain reprted assessment, dne at anther imaging facility, BIRADS 0, r partial reprt) "Cpyright 2005" 6666 02-28-05 2 f 5
Fr revised r crrected frm, check bx and fax t 215-717-0936. 14. Cntrast-enhanced breast MRI (If n breast MRI perfrmed prceed t Q17) Identify the study breast(s) n which an MRI was perfrmed in the past 11 mnths? Right (Cmplete Qs 14a, 14b, and 15) Left (Cmplete Qs 14a, 14b and 16) Bth (Cmplete Qs 14a-16a) 14a. Date f mst recent breast MRI - 14b. Specify basis fr decisin t btain the MRI Recmmended by: MD wh referred yu fr screening Anther physician (identify type f physician) Surgen Other r unknwn Smene else (specify relatinship f this persn t yu) 15. MRI Assessment f Right Breast If N evaluatin f Right Breast perfrmed, prceed t Q16 If utside study cdes as "4, suspicius", cde as 4B 15a. Assessment fr right breast 1 Negative 2 Benign 3 Prbably Benign 4A Lw Suspicin f Malignancy 4B Intermediate Suspicin 4C Mderately High Suspicin 5 Highly Suggestive f Malignancy Assessment unknwn r incmplete (unable t btain reprted assessment, dne at anther imaging facility, BIRADS 0, r partial reprt) 16. MRI Assessment f Left Breast If N evaluatin f Left Breast perfrmed, prceed t Q17 If utside study cdes as "4, suspicius", cde as 4B 16a. Assessment fr left breast 1 Negative 2 Benign 3 Prbably Benign 4A Lw Suspicin f Malignancy 4B Intermediate Suspicin 4C Mderately High Suspicin 5 Highly Suggestive f Malignancy Assessment unknwn r incmplete (unable t btain reprted assessment, dne at anther imaging facility, BIRADS 0, r partial reprt) N. 17. Other Breast Imaging (If n ther breast imaging perfrmed prceed t sectin III) Identify ther imaging perfrmed f the study breast(s) perfrmed in the past 11 mnths. NOTE: Use frms IM r F6 t reprt additinal mammgraphic r sngraphic imaging at this site as apprpriate Right (Cmplete Qs 17a, 17b, 17c and 18) Left (Cmplete Qs 17a, 17b, 17c and 19) Bth (Cmplete Qs 17a-19a) Unknwn (prceed t Q20) 17a. Specify type 17b. Date f mst recent ther imaging - 17c. Specify basis fr decisin t btain ther imaging Recmmended by: MD wh referred yu fr screening Anther physician (identify type f physician) Surgen Other r unknwn Smene else (specify relatinship f this persn t yu) 18. Other Imaging Assessment f Right Breast If N evaluatin f Right Breast perfrmed, prceed t Q19 If utside study cdes as "4, suspicius", cde as 4B 18a. Assessment fr right breast 1 Negative 2 Benign 3 Prbably Benign 4A Lw Suspicin f Malignancy 4B Intermediate Suspicin 4C Mderately High Suspicin 5 Highly Suggestive f Malignancy Assessment unknwn r incmplete (unable t btain reprted assessment, dne at anther imaging facility, BIRADS 0, r partial reprt) 19. Other Imaging Assessment f Left Breast If N evaluatin f Left Breast perfrmed, prceed t Q20 If utside study cdes as "4, suspicius", cde as 4B 19a. Assessment fr left breast 1 Negative 2 Benign 3 Prbably Benign 4A Lw Suspicin f Malignancy 4B Intermediate Suspicin 4C Mderately High Suspicin 5 Highly Suggestive f Malignancy Assessment unknwn r incmplete (unable t btain reprted assessment, dne at anther imaging facility, BIRADS 0, r partial reprt) "Cpyright 2005" 6666 02-28-05 3 f 5
Fr revised r crrected frm, check bx and fax t 215-717-0936. Sectin III. Interventin 20. Were there any cyst aspiratins, bipsies r surgeries n the study breast(s) in the past 11 mnths? N (Prceed t Q21) Yes, nt previusly reprted (Cmplete Q20a) Yes, previusly reprted (Prceed t Q21) Unknwn (Prceed t Q21) NOTE: If yes and the prcedures have nt previusly been reprted, cmplete Q20a and Frm(s) BX, NL, and S1 as apprpriate. Sectin IV. Summary/Treatment N. 21. Was a breast cancer diagnsed in the past 11 mnths? N (Cmplete Q21a) Yes, nt already reprted (Prceed t Q21b and cmplete BX and S1 frms) Yes, already reprted n BX and/r, NL and S1 (Prceed t Q22) Unknwn (Prceed t Q22) 20a. Specify interventin and date (list all that apply belw) If an interventin is n bth breasts, list each breast n a separate line. Interventin Cde Table (Q20a) 1 Cyst Aspiratin 2 FNAB (cmplete BX) 3 Cre Needle Bipsy (cmplete BX) 4 Excisinal Bipsy (cmplete NL) 5 Lumpectmy (cmplete S1) 6 Sentinel Lymph Nde (cmplete S1) 7 Axillary Lymph Nde Dissectin (cmplete S1) 8 Mastectmy (cmplete S1) 10 Other, specify (in details) 99 Specifics Unknwn Interventin Date (mm-yyyy) Details R L N/A - - - - - 21a. Mst reliable surce regarding Negative breast cancer status fr this participant. (cmplete then prceed t Q22) Participant herself says she has nt been diagnsed with breast cancer N findings reprted in participant's medical chart Participant's Primary Care Physician (PCP) (n abnrmality fund at last clinical exam) Reprt f clinical exam Other Physician (n abnrmality fund at last clinical exam) Relative r friend stated that participant has nt been diagnsed with breast cancer Participant is nt listed n the cancer registry fr the area in which she lives Hspital billing department reprts n charges fr breast cancer treatment 21b. Mst reliable surce regarding Psitive breast cancer status fr this participant. Pathlgy reprt Cancer diagnsis is reprted in participant's medical chart Participant's Primary Care Physician (PCP) reprts breast cancer Participant herself says she has been diagnsed with breast cancer Death certificate in municipality f last knwn address that lists cause f death as breast cancer Relative r friend states that participant has been diagnsed with breast cancer Participant is listed n the cancer registry fr the area in which she lives Hspital billing department reprts charges fr breast cancer treatment 21c. Site f breast cancer Right Left Bilateral "Cpyright 2005" 6666 02-28-05 4 f 5
Fr revised r crrected frm, check bx and fax t 215-717-0936. 22. Additinal treatment fr disease f the study breast(s) N (Prceed t Q23) Yes, nt previusly reprted (Cmplete Q22a) Yes, previusly reprted (Prceed Q23) Unknwn (Prceed t Q23) NOTE: Reprt all treatment that is cntinuing r new since last cntact. Prvide the start date fr each, details and site. 22a. Specify treatment and date (list all that apply belw) If an interventin is n bth breasts, list each breast n a separate line. N. Interventin Cde Table (Q22a) 1 Radiatin Therapy 2 Systemic Chemtherapy 3 Other hrmne manipulatin 9 Other, specify (in details) 99 Specifics Unknwn Interventin Date (mm-yyyy) Details R L N/A - - - - - 23. Has patient enrlled int a breast imaging trial in the past 11 mnths ther than the Screening Breast Ultrasund in High Risk Wmen Trial? N (Stp and sign frm) Yes (Cmplete Q23a) Unknwn (Stp and sign frm) 23a. Prvide name f trial Cmments: Signature f persn respnsible fr the data 1 - - Date Frm Cmpleted (mm-dd-yyyy) Signature f persn entering data nt web 2 "Cpyright 2005" 6666 02-28-05 5 f 5