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Cytokine Expression During Radiation Therapy for Breast Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
To systematically and quantitatively assess the magnitude and frequency of changes in chemo/cytokine expression in women receiving radiation therapy for breast cancer. To assess the impact of race/ethnicity on the magnitude and frequency of changes in chemo/cytokine expression during radiation therapy for breast cancer. To assess the interaction between chemo/cytokine radiation-induced expression changes, and race/ethnicity, with respect to normal tissue reactions to radiation and tumor-associated outcomes.
4.1Patient must be 18 years of age or older. 4.2Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma of the breast any T or N. No M disease. Patients with Ductal Carcinoma In Situ are eligible. Patients with squamous carcinomas or sarcomas of the breast cancer are NOT eligible. 4.3Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection (ALND) or sentinel lymph node biopsy (SNB). Patients with DCIS need not undergo SNB or ALND. Surgical. Surgical margins must be negative ( greater than or equal to 2 mm) for both invasive carcinoma and for non-invasive ductal carcinoma. Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved. Patients treated with a mastectomy are NOT eligible. 4.4Patients must be registered such that radiation therapy begins within 10 weeks of last surgery. 4.5Patients must have a performance status 0 or 1 by ECOG criteria (or a 80-100 Karnofsky Performance Scale) at time of consult. 4.6Patients must not have received prior radiation therapy to the breast at any time for any reason. 4.7Any patient with active local-regional disease prior to registration is not eligible. 4.8No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for at least 5 years. 4.9Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy. 4.10Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment. 4.11All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines. 4.12Women of all races and ethnic groups are eligible for this trial.
SCHEMA Obtain Consent *Baseline Blood Draw Whole Breast / Chest wall Radiation Therapy *Blood Draw at Radiation Fraction #10-12 (traditional fractionation) #5-6 (Canadian fractionation) *Blood Draw at Radiation Fraction #23-25 (traditional fractionation) #14-15 (Canadian fractionation) Completes radiation *Blood Draw at 6-7 month F/U *Obtain photos and skin toxicity assessments at each blood draw and follow-up visit.
08/31/2015 09:39 AM