ACOSOG-Z1041 OPEN Registration Worksheet Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder:

  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/17/21 9/17/21 -
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September 17, 2021

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Breast Cancer NCT00513292 Registration - ACOSOG-Z1041 OPEN Registration Worksheet - 3114475v1.0

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  1. StudyEvent: ACOSOG-Z1041 OPEN Registration Worksheet
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Patient Information
Gender of a Person
Method of Payment
General Information
Has patient previously been registered to an ACOSOG study
Was HIPAA Authorization included in Study Informed Consent
Stratification Factors
Clinical Tumor Size (mark one)
Hormone Receptor Status (mark one)
Age (mark one)
Eligibility Criteria
Female (Patients must be)
Age >= 18 years
ECOG Performance Status 0-1
ECOG Performance Status (0 or 1)
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy (NOTE: FNA is acceptable for evaluation of breast primaries < 2 cm and lymph node metastases)
Patients must have a breast primary >= 2.0 cm and/or one or more biopsy-positive lymph nodes (Patients with prior excisional biopsy of the breast primary are eligible, provided biopsy-positive lymph nodes are present)
The breast cancer must be determined to be HER2-positive prior to study entry (Assays performed using fluorescent in situ hybridization FISH require gene amplification. Assays using immunohistochemistry IHC require a strongly positive 3+ staining intensity score)
Within 3 months prior to entry, the patient must have a baseline left ventricular ejection fraction (LVEF) measured by MUGA scan >= 55 (Note: Echocardiogram may be substituted for MUGA at baseline, but the same method of assessment should be used throughout the study. See Section 3.1,#7 "Note" regarding LVEF and MUGA)
ANC >= 1200/mm^3
Platelet count >= 100,000/mm^3
Total bilirubin <= ULN unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin
Does this patient have a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin
Alkaline phosphatase <= 2.5 x ULN
SGOT (AST) <= 1.5 x ULN
Creatinine <= ULN
Patients with either skeletal pain or alkaline phosphatase that is > ULN but <= 2.5 x ULN are eligible for inclusion in the study if bone scans fail to demonstrate metastatic disease (Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy)
Patients with a history of DCIS or synchronous DCIS of the contralateral breast regardless of therapy are eligible (Those with synchronous invasive breast cancer are NOT eligible)
Patients with a history of ipsilateral DCIS treated by local excision with or without hormonal therapy are eligible (Those treated with radiation therapy are NOT eligible)
Patients with a history of non-breast malignancies are eligible if they have remained disease-free for 5 years since completing their initial treatment regimen and are deemed by their physician to be at low risk for recurrence (Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin)
Patients must not have had any surgical axillary staging procedure prior to study entry (However, patients who have had non-excisional biopsy of an axillary node are eligible)
Patients must not have definitive clinical or radiologic evidence of metastatic disease
Patients must not have a prior history of invasive breast cancer
Patients must not have had treatment given for this breast cancer prior to study entry (The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery.)
Patients must not be taking any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (Patients are eligible if this therapy is discontinued prior to study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy)
Patients must not be receiving therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention (Patients are eligible only if these medications are discontinued prior to study entry.)
Patients must not have had prior therapy with anthracyclines or taxanes for any malignancy
Patients must not have non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude treatment with either of the treatment regimens
Patients must not have cardiac disease that would preclude the use of epirubicin or trastuzumab (This includes: Active cardiac disease angina pectoris that requires the use of antianginal medication; cardiac arrhythmia requiring medication; severe conduction abnormality; clinically significant valvular disease; cardiomegaly on chest x-ray; ventricular hypertrophy on EKG; or poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. Patients with hypertension that is well controlled on medication are eligible. History of cardiac disease myocardial infarction documented as a clinical diagnosis or by EKG or any other tests; documented congestive heart failure; or documented cardiomyopathy)
Patients must not have sensory/motor neuropathy >= grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0
Patients must not have had administration of any investigational agents within 30 days before study entry
Women of child-bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration (Women who are breast feeding are NOT eligible. If not a female of child-bearing potential check NA)
Patients must not have psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

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