N/A
N=82
Cytokine Expression During Radiation for Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00836186 ↗Enrolled (actual)
82
Serious AEs
—
Results posted
Oct 2020
Primary outcome: Primary: Number of Proteins Expressed Differently in Response to Receiving Radiation Therapy — 31 Proteins
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Proteins Expressed Differently in Response to Receiving Radiation Therapy |
31 | — |
| SECONDARY Number of Proteins With Differential Expression by Race/Ethnicity |
4 | — |
| SECONDARY Number of Metabolites That Changed Differentially on the Basis of Patient Toxicity |
39 | — |
Summary
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.
Eligibility Criteria
INCLUSION CRITERIA
- 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
EXCLUSION CRITERIA
- 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
Data sourced from ClinicalTrials.gov (NCT00836186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.