Cytokine Expression During Radiation for Breast Cancer

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

To assess the magnitude and frequency of changes in chemo/cytokine expression in women receiving radiation treatment. To asses the impact of race/ethnicity on the magnitude and frequency of changes in chemo/cytokine expression during radiation therapy for breast cancer. And finally to assess the interaction between radiation-induced chemo/cytokine expression changes, and race/ethnicity, with respect to normal tissue reactions to radiation and tumor-associated outcomes.

Key facts

Study ID

NCT00836186

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

82

Starts

2009-11-13

Expected to finish

2019-11-01

Last updated by the study team

2020-10-08

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be 18 years of age or older
• Patients must have histologically confirmed (by routine H\&E staining) adenocarcinoma of the breast any T, any N, M0 disease
• Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of local surgery must be negative greater or equal to 2mm 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 must be registered such that radiation therapy begins within 10 weeks of last surgery
• Patients must have a performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria or a 80-100 Karnofsky Performance Scale at time of consult
• Women of all races and ethnic groups are eligible for this trial

You may not qualify if…

• Patients must not have received prior radiation therapy to the breast at any time for any reason
• Patients with squamous carcinomas or sarcomas of the breast cancer are not eligible
• Patients treated with a mastectomy are NOT eligible
• Any patient with active local-regional disease prior to registration is not eligible
• No 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
• Patients 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
• Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• The Johns Hopkins University School of Medicne — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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