A Case Report Form Packet Contents

Transcription

1 A Case Report Form Packet Contents Revision History... 3 Institutional Contacts... 4 On-Study (page 1 of 2)... 5 On-Study (page 2 of 2)... 6 Surgery: Left Breast (page 1 of 2)... 7 Surgery: Left Breast (page 2 of 2)... 8 Surgery: Right Breast (page 1 of 2)... 9 Surgery: Right Breast (page 2 of 2) Radiation Therapy: Left Breast (page 1 of 2) Radiation Therapy: Left Breast (page 2 of 2) Radiation Therapy: Right Breast (page 1 of 2) Radiation Therapy: Right Breast (page 2 of 2) On-Study: Neoadjuvant/Adjuvant Therapy Adverse Events: Baseline Supporting Documentation: Baseline Specimen Submission: Tissue (Baseline) Specimen Submission: Blood (Baseline) Specimen Submission: Urine (Baseline) PRO/QOL: Registration Fatigue/ Uniscale Assessment Compliance Patient Status: Baseline Intervention Intervention: Dose Modifications Adverse Events: Solicited (page 1 of 2) Adverse Events: Solicited (page 2 of 2) Adverse Events: Other Supporting Documentation Specimen Submission: Blood (24 months post registration) Specimen Submission: Urine (24 months post registration) PRO/QOL: Booklet Compliance Patient Status: Treatment (Intervention) tice of Invasive Breast Cancer Recurrence tice of New Primary tice of New DCIS Off Treatment

2 A Case Report Form Packet Patient Status: Survival and Disease Status Follow-Up Adverse Events: Late Consent Withdrawal Consent Withdrawal: QOL Only Consent Withdrawal: Specimen Only Consent Withdrawal: All Follow-Up Lost to Follow-Up

3 Revision History Version Date Description of Changes 1 12/08/2016 Activation 2 12/15/2017 Surgery: Left Breast Changed question text under Final Margins If the tumor does not involve the margins how close is the nearest margin? (check one) < 1mm 1-2mm > 2mm Changed dictionary values on the following question: Tumor singularity (check one) Solitary Multicentric Surgery: Right Breast Changed question text under Final Margins If the tumor does not involve the margins how close is the nearest margin? (check one) < 1mm 1-2mm > 2mm Changed dictionary values on the following question: Tumor singularity (check one) Solitary Multicentric Consent Withdrawal Removed incorrect instructions regarding Clinical Followup 3

4 Institutional Contacts INSTRUCTIONS: Use this form to identify who the Data Manager should contact for quality assurance purposes. Please update this information if there are any changes to the contact information. Cycle/Visit 0 (Baseline) (derived field) CRA Name (first, last) Phone (example, ) LEAD CRA Name (first, last) Phone (example, ) 4

5 On-Study (page 1 of 2) Cycle/Visit 0 (Baseline) (derived field) DISEASE STATUS Previous surgery related to this tumor (biopsies, resections, bypass, explorations, etc.) (check one) Yes (If yes), tumor laterality (check one) Right Left Bilateral Left breast (check one) Yes Right breast (check one) Yes Prior radiation therapy for this tumor (check one) Yes (If yes), tumor laterality Left breast (check one) Yes Right breast (check one) Yes Did the patient receive neoadjuvant/adjuvant chemotherapy? (check one) Yes (If yes), last date neoadjuvant/adjuvant chemotherapy administered (dd MMM yyyy) - - COMORBID CONDITIONS Prior history of hypertension treated with medication (check one) Yes Prior history of gastric/duodenal ulcers (non-bleeding) (check one) Yes PATIENT HISTORY Prior history of NSAID and/or aspirin use (check one) Yes (If yes), average number of times used per week in the last month PRIOR THERAPY Prior therapy (check one) Yes (If yes), Endocrine therapy (check one) Yes mtor inhibitors (Everolimus, etc. including placebo controlled trials) (check one) Yes CDK 4/6 inhibitors (Palbociclib, Abemaciclib, LEE011, etc. including placebo controlled trials) (check one) Yes Other therapy (check one) Yes Other, specify PRIOR CANCERS Has the patient had any (other) prior (invasive) cancer diagnosed? (check one) Yes (If yes), site of prior cancer (If yes), prior cancer diagnosis date (dd MMM yyyy) - - 5

6 On-Study (page 2 of 2) PATIENT CHARACTERISTICS AT RANDOMIZATION Height (without shoes) (cm) Weight (at randomization, with indoor clothing and without shoes). (kg) BMI (at randomization). ECOG Performance Status (check one) Menopausal status (check one) Pre (< 6 mo since LMP and no prior bilateral ovariectomy AND not on estrogen replacement) Post (prior bilateral ovariectomy OR >12 mo since LMP with no prior hysterectomy) Above categories not applicable AND Age < 50 Above categories not applicable AND Age >= 50 COMPANION STUDIES Did the patient consent to the optional specimen banking? (check one) Yes Did the patient consent to the optional PRO/QOL study? (check one) Yes 6

7 Surgery: Left Breast (page 1 of 2) INSTRUCTIONS: For date fields, UN should be entered if day (dd) is unknown; UNK should be selected if month (MMM) is unknown; Year (yyyy) cannot be entered as unknown. Cycle/Visit 0 (Baseline) (derived field) Primary tumor diagnosis date (dd MMM yyyy) - - Tumor singularity (check one) Solitary Multicentric Longest diameter of lesion(s). (cm) Pre-operative therapy (check one) Yes (If yes), Type of preoperative therapy Chemotherapy Hormonal (add a log line for each type of preoperative therapy) Most extensive definitive surgery for breast (check one) Most extensive definitive surgery for axilla (check one) Date of primary surgery (dd MMM yyyy) - - Sentinel lymph node (SLN) biopsy (check one) Yes Axillary lymph node dissection (ALND) (check one) Yes (If SLN biopsy and/or ALND dissection), Partial mastectomy/lumpectomy/excisional biopsy Modified radical mastectomy Skin sparing or nipple sparing mastectomy Sentinel node biopsy Level I and II axillary dissection ne Total number of lymph nodes examined (include both SLN and ALND results) Total number of positive nodes (include both SLN and ALND results) Was breast/chest wall re-excision/reoperation necessary? (check one) Yes Date of last breast tumor surgery (dd MMM yyyy) - - Did the patient undergo contralateral prophylactic mastectomy (bilateral mastectomy)? (check one) Yes FINAL MARGINS (INVASIVE OR NON-INVASIVE) Does the tumor involve the surgical margin(s)? (check one) Yes (If yes), describe the extent of margin involvement (check one) Single margin, focal Single margin, extensive Multiple margins (If yes), describe the cancer histology of margin involvement (check one) Invasive tumor (with or without DCIS/LCIS) DCIS If the tumor does not involve the margins how close is the nearest margin? (check one) < 1mm 1-2mm > 2mm 7

8 Surgery: Left Breast (page 2 of 2) TUMOR HISTOLOGY Estrogen receptor status (per institutional guidelines) (check one) Positive Negative Progesterone receptor status (per institutional guidelines) (check one) Positive Negative DISEASE STAGE Pathologic T Stage (check one) TX T0 Tis T1 T2 T3 T4 Pathologic N Stage (check one) pnx pn0 pn0(i+) pn0(i-) pn1 pn1mi pn2 pn3 Did the patient receive neoadjuvant treatment? (check one) Yes (If yes), Clinical T Stage (prior to neoadjuvant treatment) (check one) TX T0 Tis T1 T2 T3 T4 (If yes), Clinical N Stage (check one) NX N0 N1 N2 N3 BREAST RECONSTRUCTION Did the patient receive breast reconstruction? (check one) Yes, immediate Yes, delayed (If yes, immediate or yes, delayed), Type of breast reconstruction (check one) Breast implant Free flap Pedicle flap Reduction pattern / mammoplasty Tissue expander Date of last breast reconstruction surgery (dd MMM yyyy) - - 8

9 Surgery: Right Breast (page 1 of 2) INSTRUCTIONS: For date fields, UN should be entered if day (dd) is unknown; UNK should be selected if month (MMM) is unknown; Year (yyyy) cannot be entered as unknown. Cycle/Visit 0 (Baseline) (derived field) Primary tumor diagnosis date (dd MMM yyyy) - - Tumor singularity (check one) Solitary Multicentric Longest diameter of lesion(s). (cm) Pre-operative therapy (check one) Yes (If yes), Type of preoperative therapy Chemotherapy Hormonal (add a log line for each type of preoperative therapy) Most extensive definitive surgery for breast (check one) Most extensive definitive surgery for axilla (check one) Date of primary surgery (dd MMM yyyy) - - Sentinel lymph node (SLN) biopsy (check one) Yes Axillary lymph node dissection (ALND) (check one) Yes (If SLN biopsy and/or ALND dissection), Partial mastectomy/lumpectomy/excisional biopsy Modified radical mastectomy Skin sparing or nipple sparing mastectomy Sentinel node biopsy Level I and II axillary dissection ne Total number of lymph nodes examined (include both SLN and ALND results) Total number of positive nodes (include both SLN and ALND results) Was breast/chest wall re-excision/reoperation necessary? (check one) Yes Date of last breast tumor surgery (dd MMM yyyy) - - Did the patient undergo contralateral prophylactic mastectomy (bilateral mastectomy)? (check one) Yes FINAL MARGINS (INVASIVE OR NON-INVASIVE) Does the tumor involve the surgical margin(s)? (check one) Yes (If yes), describe the extent of margin involvement (check one) Single margin, focal Single margin, extensive Multiple margins (If yes), describe the cancer histology of margin involvement (check one) Invasive tumor (with or without DCIS/LCIS) DCIS If the tumor does not involve the margins how close is the nearest margin? (check one) < 1mm 1-2mm > 2mm 9

10 Surgery: Right Breast (page 2 of 2) TUMOR HISTOLOGY Estrogen receptor status (per institutional guidelines) (check one) Positive Negative Progesterone receptor status (per institutional guidelines) (check one) Positive Negative DISEASE STAGE Pathologic T Stage (check one) TX T0 Tis T1 T2 T3 T4 Pathologic N Stage (check one) pnx pn0 pn0(i+) pn0(i-) pn1 pn1mi pn2 pn3 Did the patient receive neoadjuvant treatment? (check one) Yes (If yes), Clinical T Stage (prior to neoadjuvant treatment) (check one) TX T0 Tis T1 T2 T3 T4 (If yes), Clinical N Stage (check one) NX N0 N1 N2 N3 BREAST RECONSTRUCTION Did the patient receive breast reconstruction? (check one) Yes, immediate Yes, delayed (If yes, immediate or yes, delayed), Type of breast reconstruction (check one) Breast implant Free flap Pedicle flap Reduction pattern / mammoplasty Tissue expander Date of last breast reconstruction surgery (dd MMM yyyy)

11 Radiation Therapy: Left Breast (page 1 of 2) INSTRUCTIONS: For date fields, UN should be entered if day (dd) is unknown; UNK should be selected if month (MMM) is unknown; Year (yyyy) cannot be entered as unknown. Cycle/Visit 0 (Baseline) (derived field) Radiation completed (check one) Yes (If no), radiation ongoing/planned (check one) Yes Type of radiation received (check one) Radiation therapy start date (dd MMM yyyy) - - Radiation therapy end date (dd MMM yyyy) - - Whole breast irradiation only Whole breast irradiation and regional nodal irradiation Partial breast irradiation Post mastectomy irradiation chest wall only Post mastectomy irradiation chest wall and regional nodes I. RADIATION DOSE TO WHOLE BREAST OR CHEST WALL Is total dose prior to boost known? (check one) Yes (If yes). total dose prior to boost. (Gy) Is total # (number) of fractions known? (check one) Yes (If yes), total number of fractions Boost to lumpectomy cavity or chest wall scar Was a boost given? (check one) Yes Is RT total dose to boost field known? (check one) Yes (If yes), RT total dose to boost field. (Gy) Is total # (number) of fractions to boost field known? (check one) Yes (If yes), total number of fractions to boost field Time point (check one) Intra-Op Post-Op II. RADIATION DOSE TO TARGETED REGIONAL NODES dal regions targeted Axillary Supraclavicular/axillary level 3 Internal mammary nodes (add a log line for each nodal region targeted) Is total dose to nodal regions known? (check one) Yes (If yes), total dose to nodal regions. (Gy) Is total # (number) of fractions known? (check one) Yes (If yes), total # (number) of fractions 11

12 Radiation Therapy: Left Breast (page 2 of 2) III. PARTIAL BREAST IRRADIATION Is (PBI) total dose delivered known? (check one) Yes (If yes), PBI total dose delivered. (Gy) Is (PBI) total # (number) of fractions known? (check one) Yes (If yes), PBI total number of fractions Is (PBI) # (number) of fractions delivered daily known? (check one) Yes (If yes), # (number) of fractions delivered daily Partial breast irradiation method (check one) Intraop Post-op brachytherapy device (MammoSite, contoura, ClearPath, Savi) Post-op external beam (3DCRT, IMRT, Protons) 12

13 Radiation Therapy: Right Breast (page 1 of 2) INSTRUCTIONS: For date fields, UN should be entered if day (dd) is unknown; UNK should be selected if month (MMM) is unknown; Year (yyyy) cannot be entered as unknown. Cycle/Visit 0 (Baseline) (derived field) Radiation completed (check one) Yes (If no), radiation ongoing/planned (check one) Yes Type of radiation received (check one) Radiation therapy start date (dd MMM yyyy) - - Radiation therapy end date (dd MMM yyyy) - - Whole breast irradiation only Whole breast irradiation and regional nodal irradiation Partial breast irradiation Post mastectomy irradiation chest wall only Post mastectomy irradiation chest wall and regional nodes II. RADIATION DOSE TO WHOLE BREAST OR CHEST WALL Is total dose prior to boost known? (check one) Yes (If yes). total dose prior to boost. (Gy) Is total # (number) of fractions known? (check one) Yes (If yes), total number of fractions Boost to lumpectomy cavity or chest wall scar Was a boost given? (check one) Yes Is RT total dose to boost field known? (check one) Yes (If yes), RT total dose to boost field. (Gy) Is total # (number) of fractions to boost field known? (check one) Yes (If yes), total number of fractions to boost field Time point (check one) Intra-Op Post-Op II. RADIATION DOSE TO TARGETED REGIONAL NODES dal regions targeted Axillary Supraclavicular/axillary level 3 Internal mammary nodes (add a log line for each nodal region targeted) Is total dose to nodal regions known? (check one) Yes (If yes), total dose to nodal regions. (Gy) Is total # (number) of fractions known? (check one) Yes (If yes), total # (number) of fractions 13

14 Radiation Therapy: Right Breast (page 2 of 2) III. PARTIAL BREAST IRRADIATION Is (PBI) total dose delivered known? (check one) Yes (If yes), PBI total dose delivered. (Gy) Is (PBI) total # (number) of fractions known? (check one) Yes (If yes), PBI total number of fractions Is (PBI) # (number) of fractions delivered daily known? (check one) Yes (If yes), # (number) of fractions delivered daily Partial breast irradiation method (check one) Intraop Post-op brachytherapy device (MammoSite, contoura, ClearPath, Savi) Post-op external beam (3DCRT, IMRT, Protons) 14

15 On-Study: Neoadjuvant/Adjuvant Therapy Cycle/Visit 0 (Baseline) (derived field) NEOADJUVANT / ADJUVANT CHEMOTHERAPIES Neoadjuvant chemotherapy (check one) Yes Adjuvant chemotherapy (check one) Yes Last date neoadjuvant/adjuvant chemotherapy administered (dd MMM yyyy) - - Chemotherapy regimen (neo-adjuvant/adjuvant therapies) (check one) AC + T EC + T TAC FEC/CEF FAC/CAF FEC + T FAC + T CMF TC EC AC + TC 15

16 Adverse Events: Baseline Cycle/Visit 0 (Baseline) (derived field) SOLICITED ADVERSE EVENTS Adverse event term (v4.0) Lower gastrointestinal hemorrhage Upper gastrointestinal hemorrhage MedDRA AE code (CTCAE v4.0) Adverse event not evaluated Adverse event grade Intracranial hemorrhage Adverse event grade description Epistaxis Hematuria Dyspepsia Gastritis Bruising

17 Supporting Documentation: Baseline Cycle/Visit 0 (Baseline) (derived field) # Date of assessment (dd MMM yyyy) Report type Specify report type Attachment (max file size 10 MB) - _- Pathology report Browse Imaging report - _- Pathology report Clinic note Other (add a log line for each report being attached) Browse 17

18 Specimen Submission: Tissue (Baseline) Cycle/Visit 0 (Baseline) (derived field) INSTRUCTIONS: 1. See Section of the protocol for specimen requirements and shipment. 2. Please do not submit this form with specimen shipment. Specimen type Paraffin block Was specimen submitted? Yes t submitted reason (see dictionary in Rave) t submitted reason other, specify Number of specimens submitted Date specimen collected (dd MMM yyyy) - _- Date specimen shipped (dd MMM yyyy) - _- REMINDER: All specimens must be logged in BioMS. Please see the protocol for further instructions. 18

19 Specimen Submission: Blood (Baseline) Cycle/Visit 0 (Baseline) (derived field) INSTRUCTIONS: 1. See Section of the protocol for specimen requirements and shipment. 2. Please do not submit this form with specimen shipment. Specimen type EDTA whole blood Was specimen submitted? Yes t submitted reason (see dictionary in Rave) t submitted reason other, specify Date specimen collected (dd MMM yyyy) - _- Date specimen shipped (dd MMM yyyy) - _- REMINDER: All specimens must be logged in BioMS. Please see the protocol for further instructions. 19

20 Specimen Submission: Urine (Baseline) Cycle/Visit (derived field) INSTRUCTIONS: 1. See Section of the protocol for specimen requirements and shipment. 2. Please do not submit this form with specimen shipment. Specimen type Spot urine Was specimen submitted? Yes t submitted reason (see dictionary in Rave) t submitted reason other, specify Date specimen collected (dd MMM yyyy) - _- Date specimen shipped (dd MMM yyyy) - _- REMINDER: All specimens must be logged in BioMS. Please see the protocol for further instructions. 20

21 PRO/QOL: Registration Fatigue/ Uniscale Assessment Compliance Cycle/Visit 0 (Baseline) (derived field) INSTRUCTIONS: Select the primary reason the assessment was not completed. If indicated to specify further details in primary reason, complete Specify reason assessment was not completed. Reason assessment was not completed (check one) Patient refusal: patient reported physical reason Patient refusal: patient reported mental/emotional reason Patient refusal: patient said did not like content of questions Patient refusal: patient did not give a reason Patient refusal: other, specify Unable to accommodate disability or language needs, specify t administered: staff unavailable t administered: staff did not give/offer assessment to patient t administered: staff misinterpreted protocol t administered: copy of form not available Other, specify Specify reason assessment was not completed 21

22 Patient Status: Baseline Cycle/Visit 0 (Baseline) (derived field) PROTOCOL TREATMENT Will the patient proceed to protocol treatment (intervention) for the first cycle? (check one) Yes PRO/QOL ASSESSMENT(S) Did the participant complete the PRO/QOL assessment(s)? (check one) Yes (If yes), date completed (dd MMM yyyy) - - (If yes), Was a translator used to administer the questionnaire? (check one) Yes (If yes), what was the relationship of the translator? (check one) Family/friend Professional translator Other (If other), specify (If yes), what was the language? INSTRUCTIONS: If patient WILL proceed to the first Cycle/Visit of protocol treatment, do NOT complete the remainder of this form. SURVIVAL STATUS Participant vital status (check one) Alive Dead Date of most recent contact (dd MMM yyyy) - - Death date (dd MMM yyyy) - - Date of last contact or death (dd MMM yyyy) - - (derived and hidden field) Cause of death (check one) (Primary cause of death; if cause of death is due to disease progression, select Tumor) Tumor New Primary Drug-Related Other If other cause of death, specify DISEASE STATUS Was disease status evaluated during this reporting period? (check one) Yes (If yes), date of most recent disease status evaluation (dd MMM yyyy) - - Invasive Breast Cancer Recurrence Has the patient developed an invasive (local or distant) progression or recurrence that has not been previously reported? (check one) Yes New Primary Has the patient developed a new primary (breast or non-breast) that has not been previously reported? (check one) Yes DCIS Has the patient developed new DCIS that has not been previously reported? (check one) Yes 22

23 Intervention Cycle/Visit (derived field) Weight. (kg) (used for this cycle, round to nearest tenth) BMI. Did the patient have non-protocol use of aspirin or other NSAIDs during this reporting period? (check one) Yes (If yes), frequency administered (average use per week over the last 6 months) (check one) <1 time per week 1-6 times per week Daily or more Agent name Aspirin/Placebo Dose (at Day 1 this reporting period) Units of measure mg Was the patient compliant? (defined as taking >=80% of study medication) Yes Was protocol treatment modified? Yes, planned Yes, unplanned Start date (dd MMM yyyy) - _- 23

24 Intervention: Dose Modifications Cycle/Visit (derived field) Agent name Dose modification reason (CTCAE v4.0 SOC) Aspirin/Placebo 24

25 Adverse Events: Solicited (page 1 of 2) Cycle/Visit (derived field) Reporting period end date (dd MMM yyyy) - - SOLICITED ADVERSE EVENTS Adverse event term (v4.0) MedDRA AE code (CTCAE v4.0) Adverse event not evaluated Adverse event grade (highest grade this reporting period) INCLUDE GRADE 0 s Adverse event grade description AE attribution (if grade >0) Has an adverse event expedited report been submitted? Lower gastrointestinal hemorrhage (death) Unrelated Unlikely Possible Probable Definite Yes Upper gastrointestinal hemorrhage (death) Unrelated Unlikely Possible Probable Definite Yes Intracranial hemorrhage (death) Unrelated Unlikely Possible Probable Definite Yes Epistaxis (death) Hematuria (death) Dyspepsia Gastritis (death) Bruising Unrelated Unlikely Possible Probable Definite Unrelated Unlikely Possible Probable Definite Unrelated Unlikely Possible Probable Definite Unrelated Unlikely Possible Probable Definite Unrelated Unlikely Possible Probable Definite Yes Yes Yes Yes Yes 25

26 Adverse Events: Solicited (page 2 of 2) Were (other) adverse events assessed during this reporting period? (check one) Yes, and reportable adverse events occurred (go to Adverse Events: Other CRF) Yes, but no reportable adverse events occurred 26

27 Adverse Events: Other Cycle/Visit (derived field) INSTRUCTIONS: Record all adverse events beyond those solicited; record grade 2 with attribution of possible, probable or definite and all grade 3, 4 and 5 regardless of attribution. (Both hematologic and non-hematologic adverse events must be graded on this form as applicable.) Adverse event term (v4.0) MedDRA AE code (CTCAE v4.0) Adverse event grade (highest grade this reporting period) (death) Adverse event grade description AE attribution Unrelated Unlikely Possible Probable Definite Has an adverse event expedited report been submitted?* Yes (death) Unrelated Unlikely Possible Probable Definite Yes (death) Unrelated Unlikely Possible Probable Definite Yes (death) Unrelated Unlikely Possible Probable Definite Yes (death) Unrelated Unlikely Possible Probable Definite Yes (death) Unrelated Unlikely Possible Probable Definite Yes (add a log line for each adverse event reported) *See Adverse Event Section of the Protocol v.12/10/12 27

28 Supporting Documentation Cycle/Visit (derived field) # Date of assessment (dd MMM yyyy) Report type Specify report type Attachment (max file size 10 MB) - _- Imaging report Pathology report Clinic note Other Browse 28

29 Specimen Submission: Blood (24 months post registration) Cycle/Visit (derived field) INSTRUCTIONS: 3. See Section of the protocol for specimen requirements and shipment. 4. Please do not submit this form with specimen shipment. Specimen type EDTA whole blood Was specimen submitted? Yes t submitted reason (see dictionary in Rave) t submitted reason other, specify Date specimen collected (dd MMM yyyy) - _- Date specimen shipped (dd MMM yyyy) - _- REMINDER: All specimens must be logged in BioMS. Please see the protocol for further instructions. 29

30 Specimen Submission: Urine (24 months post registration) Cycle/Visit (derived field) INSTRUCTIONS: 3. See Section of the protocol for specimen requirements and shipment. 4. Please do not submit this form with specimen shipment. Specimen type Spot urine Was specimen submitted? Yes t submitted reason (see dictionary in Rave) t submitted reason other, specify Date specimen collected (dd MMM yyyy) - _- Date specimen shipped (dd MMM yyyy) - _- REMINDER: All specimens must be logged in BioMS. Please see the protocol for further instructions. 30

31 PRO/QOL: Booklet Compliance Cycle/Visit (derived field) INSTRUCTIONS: Select the primary reason the booklet was not completed. If indicated to specify further details in primary reason, complete Specify reason booklet was not completed. Reason booklet was not completed (check one) Patient refusal: patient reported physical reason Patient refusal: patient reported mental/emotional reason Patient refusal: patient said did not like content of questions Patient refusal: patient did not want to finish booklet since didn t complete study Patient refusal: patient did not give a reason Patient refusal: other, specify Unable to accommodate disability or language needs, specify t administered: staff unavailable t administered: staff did not give/offer assessment to patient t administered: staff misinterpreted protocol t administered: patient was given wrong booklet t administered: no booklets were available to give the patient visit: patient did not complete study and was not asked to return booklet visit: no clinic visit was scheduled by mistake visit: patient missed/canceled the clinic visit visit: no clinic visit due to treatment hold or delay visit: other, specify At home booklet not returned: patient did not complete study and was not asked to return booklet At home booklet not returned: patient indicated booklet was returned, but it was not received by site At home booklet not returned: reason unknown At home booklet not returned: other, specify Patient died Other, specify Specify reason booklet was not completed 31

32 Patient Status: Treatment (Intervention) Cycle/Visit (derived field) SURVIVAL STATUS Participant vital status (check one) Alive Dead Date of most recent contact (dd MMM yyyy) - - Death date (dd MMM yyyy) - - Date of last contact or death (dd MMM yyyy) - - (derived and hidden field) Cause of death (check one) (Primary cause of death; if cause of death is due to disease progression, select Tumor) Tumor New Primary Drug-Related Other If other cause of death, specify DISEASE STATUS Was disease status evaluated during this reporting period? (check one) Yes (If yes), date of most recent disease status evaluation (dd MMM yyyy) - - Invasive Breast Cancer Recurrence Has the patient developed an invasive (local or distant) progression or recurrence that has not been previously reported? (check one) Yes New Primary Has the patient developed a new primary (breast or non-breast) that has not been previously reported? (check one) Yes DCIS Has the patient developed new DCIS that has not been previously reported? (check one) Yes PROTOCOL TREATMENT Will the patient continue protocol treatment (intervention) in the subsequent cycle? (check one) Yes PRO/QOL ASSESSMENT(S) te: If PRO/QOL is expected at the current time point, answer Yes or to the following question. If PRO/QOL is not expected at the current time point, answer t applicable. Did the participant complete the PRO/QOL assessment(s)? (check one) Yes t applicable (If yes), date completed (dd MMM yyyy) - - SPECIMENS FOR BANKING Were specimens for banking submitted this cycle? (check one) Yes 32

33 tice of Invasive Breast Cancer Recurrence Cycle/Visit (derived field) Local-regional recurrence (check one) Yes (If yes), Date of local (regional) recurrence (dd MMM yyyy) - - Site(s) of local-regional recurrence Ipsilateral breast (check one) Yes Chest wall (check one) Yes Axillary node(s) (check one) Yes Internal mammary node (check one) Yes Infraclavicular node(s) (check one) Yes Supraclavicular nodes (check one) Yes Other (check one) Yes If other, specify Distant recurrence (check one) Yes (If yes), Date of distant recurrence (dd MMM yyyy) - - Site(s) of distant recurrence Bone (check one) Yes Liver (check one) Yes Lung (check one) Yes CNS (check one) Yes Other (check one) Yes If other, specify 33

34 tice of New Primary Cycle/Visit (derived field) NOTE: Do not report squamous or basal cell skin cancer, melanoma in situ, carcinoma of the cervix, or colon carcinoma in situ. NOTICE OF NEW PRIMARY Location of new primary Invasive ipsilateral breast Invasive contralateral breast Acute Myelogenous Leukemia (AML) Ovary Thyroid Uterus Colon Lung Myelodysplastic Syndrome (MDS) Acute Lymphoblastic Leukemia (ALL) Other If other, specify New primary cancer date (dd MMM yyyy) - - (add a new logline for each new primary) 34

35 tice of New DCIS Cycle/Visit (derived field) Location of DCIS Left Right Date of tissue diagnosis of DCIS (dd MMM yyyy) - - Left - - Right (Add a new logline for each new DCIS) 35

36 Off Treatment Last date protocol treatment/intervention (any modality) given (dd MMM yyyy) - - (date of last treatment (intervention) dose on this study or date decision made not to initiate protocol treatment (e.g. surgery, radiation, ablation)) Off treatment (intervention) date (dd MMM yyyy) - - (date decision was made to end active treatment or not to initiate protocol treatment (e.g. surgery, radiation, ablation) Off treatment (intervention) reason (check one) Treatment Completed Per Protocol Criteria Disease Progression, Relapse During Active Treatment Disease Progression Before Active Treatment Adverse Event/Side Effects/Complications Alternative Therapy Patient Off-Treatment For Other Complicating Disease Death On Study Patient Withdrawal/Refusal After Beginning Protocol Therapy Patient Withdrawal/Refusal Prior to Beginning Protocol Therapy Other Off treatment (intervention) reason other, specify 36

37 Patient Status: Survival and Disease Status Follow-Up Cycle/Visit (derived field) Were you able to obtain any information about the patient since the last report? (check one) Yes (If no), date of last attempt to contact patient (dd MMM yyyy) - - (If no, end form) SURVIVAL STATUS Participant vital status (check one) Alive Dead Date of most recent contact (dd MMM yyyy) - - Death date (dd MMM yyyy) - - Date of last contact or death (dd MMM yyyy) - - (derived and hidden field) Cause of death (check one) (Primary cause of death; if cause of death is due to disease progression, select Tumor) Tumor New Primary Drug-Related Other If other cause of death, specify DISEASE STATUS Was disease status evaluated during this reporting period? (check one) Yes (If yes), date of most recent disease status evaluation (dd MMM yyyy) - - Invasive Breast Cancer Recurrence Has the patient developed an invasive (local or distant) progression or recurrence that has not been previously reported? (check one) Yes New Primary Has the patient developed a new primary (breast or non-breast) that has not been previously reported? (check one) Yes DCIS Has the patient developed new DCIS that has not been previously reported? (check one) Yes FIRST NON-PROTOCOL TREATMENT Has the patent received non-protocol treatment for this cancer that has not been previously reported? (check one) Yes PRO/QOL ASSESSMENT(S) te: If PRO/QOL is expected at the current time point, answer Yes or to the following question. If PRO/QOL is not expected at the current time point, answer t applicable. Did the participant complete the PRO/QOL assessment(s)? (check one) Yes t applicable (If yes), date completed (dd MMM yyyy) - - LATE ADVERSE EVENTS Has the patient had a grade 3+ adverse event that has not been previously reported? (check one) Yes 37

38 Adverse Events: Late Adverse event term (v4.0) MedDRA AE code (CTCAE v4.0) Adverse event grade Adverse event grade description AE attribution AE start date (dd MMM yyyy) (death) Unrelated Unlikely Possible Probable Definite (death) Unrelated Unlikely Possible Probable Definite (death) Unrelated Unlikely Possible Probable Definite (death) Unrelated Unlikely Possible Probable Definite (death) Unrelated Unlikely Possible Probable Definite (death) Unrelated Unlikely Possible Probable Definite - - (add a log line for each late adverse event reported) (death) Unrelated Unlikely Possible Probable Definite

39 Consent Withdrawal INSTRUCTIONS: If a study participant is refusing further study treatment, document the refusal by completing an Off Treatment form, and select Form added in error. Form added in error INSTRUCTIONS: Select consent withdrawal for all follow-up if the participant is withdrawing consent for all further followup, this would include clinical, specimen and QOL, and any additional follow-up. Select type(s) of withdrawal below (check all that apply) Consent withdrawal for QOL (patient reported outcomes) only Consent withdrawal for all specimens only Consent withdrawal for all follow-up 39

40 Consent Withdrawal: QOL Only INSTRUCTIONS: A Consent Withdrawal: QOL Only form should be completed if a study participant is not willing to complete QOL assessments. Date study participant withdrew consent (dd MMM yyyy) - - Site investigator notified (check if notified) 40

41 Consent Withdrawal: Specimen Only INSTRUCTIONS: A Consent Withdrawal: Specimen Only form should be completed if a study participant is no longer willing to have their specimen(s) used for research. Date study participant withdrew consent (dd MMM yyyy) - - Site investigator notified (check if notified) 41

42 Consent Withdrawal: All Follow-Up INSTRUCTIONS: A Consent Withdrawal: All Follow-Up form should be completed if the study participant is not willing to be contacted for further follow-up. Date study participant withdrew consent (dd MMM yyyy) - - Site investigator notified (check if notified) 42

43 Lost to Follow-Up Date study participant deemed lost to follow-up (dd MMM yyyy) - - INSTRUCTIONS: A study participant can be declared lost if attempts have been unsuccessful after 2 years without contact. Please indicate which steps below were taken to contact the study participant. Researched Social Security Death Index and found no information for this study participant, specify most recent date (dd MMM yyyy) - - Sent certified or registered international letter to last known address, specify most recent date sent (dd MMM yyyy) - - Result of certified or registered international letter Other method, specify Letter returned unclaimed or marked addressee unknown response 1 month after confirmed receipt of letter Other Site Investigator notified OFFICE USE ONLY: Central reviewer agrees study participant has been deemed lost to follow-up according to the required criteria 43