Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2012-10"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2013-01-18"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2013-01-21"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "<p>OBJECTIVES:</p><p>Primary</p><ul><li>To assess the local recurrence (LR) rate with breast-conservation in patients with multiple ipsilateral primary breast cancer (MIBC).</li></ul><p>Secondary</p><ul><li>To examine the conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting breast-conservation surgery (BCS) or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease.</li><li>To assess patient's perception of cosmesis and incidence of breast lymphedema.</li><li>To examine the type and severity of adverse effects of BCS and radiation for women with MIBC.</li><li>To examine the radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site.</li><li>To evaluate protein and gene expression patterns in tissue taken from each breast lesion and to evaluate the concordance of the findings between these lesions.</li><li>To compare the extent of disease described on imaging (mammography, bilateral breast magnetic resonance imaging [MRI] and other adjunctive imaging modalities) with surgical findings.</li></ul><p>OUTLINE: This is a multicenter study.</p><p>Patients undergo breast-conserving surgery (BCS) with all lesions resected to negative margins using 1 lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the surgeon.\nPatients receive adjuvant chemotherapy and/or endocrine therapy at the discretion of the treating medical oncologist based on tumor characteristics.</p><p>Within 6-10 weeks after surgery or 8 weeks after completion of cytotoxic chemotherapy, patients undergo adjuvant whole-breast irradiation (WBI) with a boost to the lumpectomy bed of each site of disease 5 days a week for approximately 6 weeks.</p><p>Patients complete the Breast-Conserving Therapy Module (BREAST-Q© subscales) questionnaire 5-30 days after surgery and every 6 months for the first 2 years and the yearly for the next 3 years after WBI.\nPatients' surgeons also complete the questionnaire 5-30 days after performing final surgery to assess cosmetic outcomes.</p><p>Formalin-fixed paraffin-embedded (FFPE) tissue block from each site of disease are collected during BCS for protein and gene expression pattern studies.\nBlood samples may be also collected at baseline and during BCS.</p><p>After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly for years 3-5.</p>"
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>DISEASE CHARACTERISTICS:</p><ul><li><p>Upon clinical exam and pre-operative imaging by MRI and mammogram both, two or three foci of biopsy-proven breast cancer separated by ≥ 3 cm of normal breast tissue on clinical exam and preoperative imaging; foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS); no more than 2 quadrants with biopsy-positive breast cancer</p><ul><li>Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram and MRI only</li></ul></li><li>Bilateral mammogram ≤ 60 days prior to registration</li><li>Bilateral breast MRI ≤ 45 days prior to registration</li><li><p>cN0 or cN1 disease</p><ul><li>No cNX, cN2, or cN3 disease</li></ul></li><li>Willing to provide tissue samples for correlative research purposes</li><li>Largest single focus of disease > 5 cm by either mammogram or MRI or both (measurement of the largest single focus should include any satellite lesions within 1 cm of the index lesion)</li><li>No clinical or radiographic evidence of metastatic disease</li><li>No prior or current lobular carcinoma in situ (LCIS), DCIS, or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed)</li><li>No patients with known BRCA mutations</li></ul><p>PATIENT CHARACTERISTICS:</p><ul><li>Life expectancy of at least 5 years, excluding diagnosis of breast cancer (comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)</li><li>Men are excluded from this study</li><li>Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2</li><li>Hemoglobin (Hgb) ≥ 8 g/dL</li><li>Peripheral platelet count (PLT) ≥ 50,000/mm³</li><li>Ability to complete questionnaire(s) by themselves or with assistance</li><li>Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study</li><li>Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only</li><li><p>None of the following:</p><ul><li>Pregnant women</li><li>Nursing women</li><li>Women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)</li></ul></li><li>No co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole-breast irradiation (such as connective tissue disorders, lupus, or scleroderma)</li><li>No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements</li><li><p>No other active malignancy ≤ 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix</p><ul><li>If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer</li></ul></li></ul><p>PRIOR CONCURRENT THERAPY:</p><ul><li><p>No surgical axillary staging procedure prior to study entry</p><ul><li>Fine-needle aspiration (FNA) or core-needle biopsy of axillary node is permitted</li></ul></li><li><p>No breast implants at time of diagnosis</p><ul><li>Patients who have had implants previously removed prior to diagnosis are eligible</li></ul></li><li>No treatment including radiation therapy, chemotherapy, biotherapy, or hormonal therapy for this cancer prior to registration</li><li>No neoadjuvant endocrine therapy or neoadjuvant hormonal therapy</li><li>No planned partial-breast radiation</li><li>No administration of any investigational agent ≤ 30 days prior to registration</li></ul>"
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"zip": "19958",
"city": "Lewes",
"state": "Delaware",
"status": "RECRUITING",
"country": "United States",
"contacts": [
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"name": "Clinical Trials Office - Tunnell Cancer Center",
"role": "CONTACT",
"phone": "302-645-3171"
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"facility": "Tunnell Cancer Center at Beebe Medical Center",
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"city": "Newark",
"state": "Delaware",
"status": "RECRUITING",
"country": "United States",
"contacts": [
{
"name": "Clinical Trial Office - CCOP - Christiana Care Health Services",
"role": "CONTACT",
"phone": "302-623-4450"
}
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"city": "Avon",
"state": "Indiana",
"status": "RECRUITING",
"country": "United States",
"contacts": [
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"name": "Linda K. Han",
"role": "CONTACT",
"phone": "317-217-3000"
}
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"facility": "Clarian West Medical Center",
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"country": "United States",
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"role": "CONTACT",
"phone": "317-688-2000"
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"city": "Elkhart",
"state": "Indiana",
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"country": "United States",
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"name": "Robin Zon, MD",
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"zip": "46202-5289",
"city": "Indianapolis",
"state": "Indiana",
"status": "RECRUITING",
"country": "United States",
"contacts": [
{
"name": "Clinical Trials Office - Indiana University Cancer Center",
"role": "CONTACT",
"phone": "317-274-2552"
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"facility": "Indiana University Melvin and Bren Simon Cancer Center",
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"city": "Indianapolis",
"state": "Indiana",
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"country": "United States",
"contacts": [
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"name": "Linda K. Han",
"role": "CONTACT",
"phone": "317-639-6671"
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],
"facility": "William N. Wishard Memorial Hospital",
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"state": "Indiana",
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"country": "United States",
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"role": "CONTACT",
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"city": "La Porte",
"state": "Indiana",
"status": "RECRUITING",
"country": "United States",
"contacts": [
{
"name": "Robin Zon, MD",
"role": "CONTACT",
"phone": "574-296-6536"
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"facility": "Center for Cancer Therapy at LaPorte Hospital and Health Services",
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"zip": "46545-1470",
"city": "Mishawaka",
"state": "Indiana",
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"country": "United States",
"contacts": [
{
"name": "Robin Zon, MD",
"role": "CONTACT",
"phone": "574-296-6536"
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"city": "Plymouth",
"state": "Indiana",
"status": "RECRUITING",
"country": "United States",
"contacts": [
{
"name": "Robin Zon, MD",
"role": "CONTACT",
"phone": "574-296-6536"
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],
"facility": "Michiana Hematology Oncology PC - Plymouth",
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"city": "South Bend",
"state": "Indiana",
"status": "RECRUITING",
"country": "United States",
"contacts": [
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"name": "Robin Zon, MD",
"role": "CONTACT",
"phone": "574-296-6536"
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],
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"state": "Indiana",
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"country": "United States",
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"role": "CONTACT",
"phone": "800-284-7370"
}
],
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"city": "Westville",
"state": "Indiana",
"status": "RECRUITING",
"country": "United States",
"contacts": [
{
"name": "Robin Zon, MD",
"role": "CONTACT",
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"state": "Kansas",
"status": "RECRUITING",
"country": "United States",
"contacts": [
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"name": "Rakesh Gaur, MD",
"role": "CONTACT",
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}
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"role": "CONTACT",
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"city": "Prairie Village",
"state": "Kansas",
"status": "RECRUITING",
"country": "United States",
"contacts": [
{
"name": "Rakesh Gaur, MD",
"role": "CONTACT",
"phone": "913-948-5588"
}
],
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"state": "Kentucky",
"status": "RECRUITING",
"country": "United States",
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{
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"name": "Diana Dickson-Witmer",
"role": "CONTACT",
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],
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}
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"role": "CONTACT",
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],
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"name": "Robin Zon, MD",
"role": "CONTACT",
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"name": "Rakesh Gaur, MD",
"role": "CONTACT",
"phone": "913-948-5588"
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],
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"country": "United States",
"contacts": [
{
"name": "Rakesh Gaur, MD",
"role": "CONTACT",
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}
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],
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"state": "Missouri",
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"country": "United States",
"contacts": [
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"state": "Missouri",
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"country": "United States",
"contacts": [
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"name": "Julie A. Margenthaler",
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"phone": "314-747-7222"
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"city": "Voorhees Township",
"state": "New Jersey",
"status": "RECRUITING",
"country": "United States",
"contacts": [
{
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],
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"country": "United States",
"contacts": [
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],
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