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Title:
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A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy - IRB# 09-023B
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Treatments:
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HER2 Testing, Radiation Therapy, Trastuzumab
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Disease Site:
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Breast
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Disease SubSite:
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DCIS
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Drug Provided:
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HER2 Testing, Trastuzumab
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Comments:
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Eligibility:
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Histologically confirmed ductal carcinoma in situ (DCIS), Mixed DCIS and lobular carcinoma in situ (LCIS) allowed, HER2 receptor-positive as determined by central testing. Must have undergone resection by lumpectomy and meets the following criteria: Margins of the resected specimen must be histologically free of DCIS (re-excision to obtain clear margins allowed), No more than 120 days since the last surgery for excision of DCIS (lumpectomy or re-excision of lumpectomy margins), None of the following allowed: Patients who require mastectomy, Invasive (including microinvasion staged as T1mic) breast cancer (DCIS “suspicious” for microinvasion, but not confirmed, allowed), Nodal staging of pN1 (including pN1mi) (axillary staging not required), DCIS present in more than one quadrant (multicentric), Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign, Contralateral breast cancer (including DCIS), History of breast cancer, including DCIS (history of LCIS allowed). Hormone receptor status: Estrogen receptor and/or progesterone receptor-positive or –negative, Must submit tumor block for correlative studies. Prior/Concurrent Therapy: See Disease Characteristics, No prior whole or partial breast irradiation, No prior anthracycline chemotherapy for any malignancy, No investigational agents within the past 30 days, No other cancer therapy until the time of first cancer recurrence or second primary cancer.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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