NSABP Protocol B-47 Worksheet for Form Entry A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node- Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer Source Form: NCI FormBuilder:

  1. 8/8/14 8/8/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
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September 20, 2021

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Breast Cancer NCT01275677 Registration - NSABP Protocol B-47 Worksheet for Form Entry - 3155372v1.0

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  1. StudyEvent: NSABP Protocol B-47 Worksheet for Form Entry
    1. No Instruction available.
Intended chemotherapy regimen
Has the patient authorized the release of Protected Health Information to the NSABP?
Did the patient consent to use of blood samples for research related to this study?
Did the patient consent to use of blood samples for the B-47 Menstrual History study?
Did the patient consent to future contact about more research?
Section 2 - Diagnostic
IHC Staining Score (If multiple IHC assays were performed, report the one with the highest staining intensity score. Please refer to Protocol - Section 4.2.7 for more information. - A copy of the IHC report must be provided.)
Was HER2 status assessed by ISH assay
Was HER2 to CEP17 ratio performed?
Section 4 - Surgery After Neoadjuvant Chemotherapy1
Does the patient have unilateral invasive adenocarcinoma of the breast on histologic examination?
Tumor Laterality
Was lumpectomy performed?
Was total mastectomy performed?
Were mastectomy margins free of gross residual tumor?
Were mastectomy margins microscopically positive?
Will post-mastectomy RT of the chest wall be administered?
Were lumpectomy margins histologically free of invasive tumor and DCIS, either initially or after one or more re-excisions?
Was estrogen receptor status determined from the primary tumor?
Receptor Status, ER
Was progesterone receptor status determined from the primary tumor?
Receptor Status, PgR
Histologic Type (Mark predominant tumor type.)
Histologic Grade (Use combined histologic grade classification.)
Was Oncotype DX Recurrence Score determined?
Was sentinel lymphadenectomy performed?
Surgical Procedure for Evaluation of Pathological Nodal Status
Pathologic T Stage
Pathologic N Stage (pathologic evaluation of ipsilateral nodes)
Patient Characteristics
Are anti-hypertensive medication(s) needed to sustain systolic BP <= 150 mmHg and diastolic BP <= 90 mmHg?
Assessment Type
Section 3 (continued)
Platelet Count
Section 3 (continued)
ALT (required only when SGOT AST is not available)
Alkaline Phosphatase
Total Bilirubin
Serum Creatinine
Baseline Values2
Was liver imaging performed? (CT, MRI, PET scan, or PET-CT)
Does liver imaging demonstrate metastatic disease?
Does the patient have unexplained bone pain?
Was bone scan, PET-CT scan, or PET scan performed?
Does bone scan, PET-CT scan, or PET scan demonstrate metastatic disease?
Is bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin?
Was chest imaging performed?
Did chest imaging demonstrate metastatic disease?
Section 4 - Patient History
Was the breast cancer staged as T4, including inflammatory breast cancer?
Is there definitive clinical or radiologic evidence of metastatic disease for this patient?
Did the patient have synchronous or previous contralateral invasive breast cancer?
Does the patient have a history of ipsilateral invasive breast cancer or ipsilateral DCIS?
Does the patient have a history of non-breast malignancies within the past 5 years?
Were the other malignancies limited to one or more of the following: in situ cancers treated only by local excision, and basal and squamous cell carcinomas of the skin?
Has the patient had previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy?
Has the patient had chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer?
Has the patient had whole breast RT prior to randomization or partial breast RT that cannot be completed on or before the date of randomization?
Will the patient receive continued endocrine therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor after randomization?
Will the patient receive continued sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy after randomization?
Does the patient have angina pectoris that requires the use of anti-anginal medication?
Does the patient have ventricular arrhythmias except for benign premature ventricular contractions?
Does the patient have supraventricular or nodal arrhythmias requiring a pacemaker or not controlled with medication?
Does the patient have a conduction abnormality requiring a pacemaker?
Does the patient have valvular disease with documented compromise in cardiac function?
Does the patient have symptomatic pericarditis?
Does the patient have a history of documented CHF?
Does the patient have a history of documented cardiomyopathy?
Does the patient have a history of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function?
Does the patient have any other cardiac disease (history of and/or active disease) that would preclude the use of drugs included in the treatment regimen?
Does the patient have active hepatitis B or hepatitis C with abnormal liver function tests?
Does the patient have intrinsic lung disease resulting in dyspnea?
Does the patient have poorly controlled diabetes mellitus?
Does the patient have active infection or chronic infection requiring chronic suppressive antibiotics?
Does the patient have a nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the CTCAE v4.0?
Does the patient have any conditions that would prohibit administration of corticosteroids?
Does the patient have known hypersensitivity reaction to any of the study drugs or excipients, e.g. polysorbate 80 and Cremophor EL?
Does the patient have chronic daily treatment with corticosteroids with a dose >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)?
Does the patient have other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up?
Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
Has the patient used any investigational product within the past 30 days?
Is patient a woman of childbearing potential?
Was a pregnancy test performed?
Is the patient pregnant or lactating at time of study entry?
Does the patient have an ECOG performance status of 0 or 1?
Section 5 - Menapausal Status
Has the patient had a hysterectomy?
Has the patient had any spontaneous menses in the past 12 months?
Has the patient had both ovaries removed?
Has the patient had a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard? (If yes, please provide documentation of estradiol level.)

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