Study Summary
This trial studies how well a single session of radiation therapy works in treating patients with early stage breast cancer.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 9 Secondary · Reporting Duration: Up to 5 years
Up to 5 years
Cosmesis as measured qualitatively
Cosmesis as measured quantitatively
Frequency of any grade 3-4 toxicities using CTCAE v4.0
Presence of complications using CTCAE v. 4.0
Proportion of patients surviving
Proportion of patients undergoing mastectomy
Proportion of patients who are free from distant metastases
Proportion of patients who are free of breast cancer in the regional lymph nodes
Proportion of patients who are free of breast cancer in the treated breast
Proportion of patients who are free of serious treatment related toxicity
Quality of life
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment (HG-PBI)
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: accelerated partial breast irradiation · No Placebo Group · N/A
Treatment (HG-PBI)
Radiation
Experimental Group · 1 Intervention: accelerated partial breast irradiation · Intervention Types: RadiationTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
accelerated partial breast irradiation
2009
N/A
~140
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,822 Previous Clinical Trials
2,283,958 Total Patients Enrolled
45 Trials studying Breast Cancer
8,244 Patients Enrolled for Breast Cancer
Imran Zoberi, M.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
326 Total Patients Enrolled
2 Trials studying Breast Cancer
207 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · Female Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a specific type of early-stage breast cancer that is not too big and does not have a genetic mutation called HER2/neu.
You have already gone through menopause.
You are 50 years old or older when you were diagnosed.
You have early-stage breast cancer that has not spread to the lymph nodes and was treated with partial mastectomy. The size of your tumor will be determined by a doctor. If you have invasive cancer, no lymph nodes can be affected and at least 6 lymph nodes should be sampled or the sentinel node should be negative.
Any cancerous tissue removed during surgery must have clear margins, meaning there is no cancer within 2mm of the edge of the removed tissue.
If you plan to receive systemic therapy, it must be given as a follow-up treatment and not start until at least 4 weeks after completing HG-PBI.
Your doctor thinks you are a suitable candidate for the treatment plan outlined in the study.
You understand and agree to sign a document that explains the study and your participation in it.
You must be able to speak English.
Frequently Asked Questions
Are there still vacancies available for those wishing to participate in this clinical trial?
"According to the information listed on clinicaltrials.gov, recruitment for this trial has concluded and it is not presently seeking applicants. This study was first posted in April of 2014 with its last update taking place November 14th 2022; however, there are over two thousand other trials currently recruiting patients." - Anonymous Online Contributor
Unverified Answer