Description:

NSABP B-45 Worksheet for Entry Form Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6461E18A-2104-98F1-E040-BB89AD4303E7

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6461E18A-2104-98F1-E040-BB89AD4303E7

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Versions (4) ▾
  1. 8/8/14
  2. 8/11/14
  3. 1/9/15
  4. 9/17/21
Uploaded on:

September 17, 2021

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License:
Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00914043 Registration - NSABP B-45 Worksheet for Entry Form - 2846518v1.0

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

Header
Patient Gender
Race
Race (more than one may be marked)
Person Completing Form, Last Name
Method of Payment (mark primary method only)
Ethnicity
Country of residence
Unnamed4
Was this an IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and release of required tumor blocks
Did the patient consent to future contact about more research
Did the pathology department agree to release the required blocks
Did the patient agree to have a blood sample collected before starting study drug
Has the patient authorized the release of Protected Health Information to the NSABP?
Did the patient complete the Quality of Life baseline form?
Cardiac Conditions
Angina pectoris that requires the use of anti-anginal medication
Serious cardiac arrythmia requiring medication?
Valvular disease with documented cardiac function compromise?
Does the patient have a history of myocardial infarction
History of documented congestive heart failure
Severe conduction abnormality?
Uncontrolled hypertension defined as BP > 150/90 on antihypertensive therapy
Was there documentation of elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function
Other Conditions
Has the patient had contralateral breast cancer (including DCIS) at any time
Has the patient had any prior cancer diagnosed?
Is the patient deemed by her physician to be a low risk for recurrence (If yes)
Has the patient been disease free for 5 years or more
Does the patient have a history of hypertensive crisis or hypertensive encephalopathy
Does the patient have a history of arterial thrombotic event within the past 12 months (including catheter-related thrombus)
Does the patient have a history of ipsilateral breast cancer (including DCIS)
Has the patient had any prior malignancies in the past 5 years other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the colon or rectum, or carcinoma in situ of the cervix that has been effectively treated? (If the patient has not been disease free for 5 years or more)
Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?
Has the patient had any significant non-traumatic bleeding within 6 months before study entry
Cardiac Risk Factors
Does the patient have any first degree relatives who died from heart disease before the age of 55 (First degree relatives are parents, children, brothers, and sisters)
Hypertension requiring medical therapy (If yes, mark all categories that apply)
Diabetes requiring medical therapy
Hyperlipidemia requiring medical therapy
Smoking (Patient History)
Section 2 - Diagnostic
Stage (Clinical)
Is estrogen receptor analysis result available (from primary surgery)
Receptor Status, ER (If yes,)
Was there any histologic evidence of invasive tumor cells in the surgical breast specimen
Is progesterone receptor analysis result available (from primary surgery)
Receptor Status, PgR
Was HER2 status assessed by IHC assay
Her2/neu expression status by immunohistochemistry
Was HER2 status assessed by ISH assay (FISH, CISH, or other ISH)
HER2 Status by ISH Assay (If yes, If multiple ISH assays were done, and at least one was positive, the positive assay must be reported.)
Was HER2-targeted therapy administered pre-operatively or post-operatively prior to study entry (If ISH assay is equivocal,)
Is there a plan to administer HER2-targeted therapy
Nodal Status Assessments Prior To Neoadjuvant Chemotherapy
Was nodal FNA performed
Was nodal FNA positive
Was nodal core biopsy performed
Was nodal core biopsy positive
Was sentinel node sampling performed
Were there any positive sentinel nodes
Section 3 - Neoadjuvant Chemotherapy
Neoadjuvant Chemotherapy
Section 4 - Surgery After Neoadjuvant Chemotherapy
Tumor Laterality
Margin Status (If mastectomy was performed,)
Is estrogen receptor analysis result available (from primary surgery)
Receptor Status, ER (If yes,)
Does the pathology report from the breast surgery indicate on H&E staining that residual invasive in-breast disease was found in the surgical specimen
Size of residual tumor (If yes, If > 0.5 cm, refer to Protocol Table 3.)
Pathologic N Stage (If no,)
Has the patient recovered from surgery
Section 4 - Surgery After Neoadjuvant Chemotherapy1
Was lumpectomy performed
Was mastectomy performed
Were lumpectomy margins histologically free of invasive tumor and DCIS, either initially or after one or more re-excisions (If mastectomy was not performed,)
Is progesterone receptor analysis result available (from primary surgery)
Receptor Status, PgR
Was axillary staging performed
Does the pathology report from the axillary staging procedure indicate on H&E staining that residual axillary nodal metastasis was found in the surgical specimen
Size of largest focus of nodal metastasis (If yes, If > 0.5 cm, refer to Protocol Table 3)
Will postoperative radiation therapy be administered after the patient has been entered on study
Has the incision completely healed with no signs of infection (If yes,)
Sentinel Node Biopsy Staging
Was sentinel node biopsy (SNB) performed after neoadjuvant therapy
Other Axillary Staging
Number of axillary staging procedures (other than SNB) performed after neoadjuvant therapy (If 1 or 2, list dates and nodal information)
Postoperative Chemotherapy
Postoperative Chemotherapy (If no, skip to B Baseline Values)
Types of Postoperative Chemotherapy (Mark all that apply)
Did the patient experience chemotherapy-related toxicity (excluding alopecia, nail changes, dysgeusia, hot flashes/flushes, sexual/reproductive function)
Have these toxicities resolved to <= grade 1 (If yes,)
Baseline Values
Hypertension requiring medical therapy (If yes, mark all categories that apply)
Anti-Hypertensive Drugs (for management of hypertension)
Patient Characteristics
cm
Kg
Baseline Values1
seconds
%
Assessment Type (A copy of the echocardiogram or MUGA scan report must be provided. If this document does not report LVEF as a whole number, see Protocol Section 5.3 for rounding instructions)
Urine Protein
Was 24-hour urine specimen collected (If >= 2+,)
g/24 hours
Blood Counts
Does the patient require chronic supplementation for serum phosphate levels
Does the patient have Gilbert's disease or a similar syndrome due to slow conjugation of bilirubin (If Total Bilirubin is > ULN and <= 1.5 x ULN)
Baseline Values2
Was liver imaging performed (If AST, ALT, or alkaline phosphatase is higher than ULN)
Was gross extrahepatic disease identified (If yes,)
Does the patient have symptomatic pancreatitis
Does the patient have bone pain
Was at least one bone scan or PET scan performed (If patient has skeletal pain or alkaline phosphatase is higher than ULN)
Did any bone scan or PET scan demonstrate metastatic disease (If yes,)
Were there suspicious findings on bone scan or PET scan (If no,)
Were the suspicious findings confirmed as benign by x-ray, MRI, or biopsy (If yes,)
U/L
U/L
U/L
U/L
Other
ECOG Performance Status (Patient)
Is metastatic breast cancer present
Has the patient had prior therapy with angiogenesis inhibitors, for example bevacizumab and sorafenib
Does the patient have the ability to swallow oral medication
Has the patient had partial breast irradiation (PBI)
Is there a plan to administer PBI following randomization
Other1
Does the patient require medication having proarrhythmic potential, for example terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide
Does the patient have a history of symptomatic peripheral vascular disease
Does the patient have active gastroduodenal ulcer(s) determined by endoscopy to be active?
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of entry, or is there anticipation of a need for major surgical procedure during the course of the study?
Is the patient having ongoing treatment with therapeutic doses of warfarin
Is the patient on any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, SERMS other than tamoxifen and toremifene, systemic estrogen or progesterone replacement therapy or contraceptive products
Will the medication(s) be discontinued prior to randomization (If yes,)
Does the patient plan to have reconstructive surgery or other major surgical procedures during the course of the study
Other2
Has the patient had hyperthyroidism within 6 months prior to randomization
Does the patient have a non-healing wound, skin ulcers, or incompletely healed bone fracture
Does the patient have malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function
Does the patient have known bleeding diathesis or coagulopathy
At the time of study entry, will the patient be pregnant or lactating
Has the patient had any investigational agents within 30 days before randomization
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