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Radiation
Accelerated Radiation Therapy for Breast Cancer
N/A
Waitlist Available
Led By Harriet Eldredge-Hindy, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women with invasive breast cancer who have undergone axillary staging and must begin adjuvant therapy within 9 weeks following the last surgery
Women with histologically confirmed ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 years post completion of ahf-rt
Awards & highlights
Study Summary
This trial will test whether a shorter, more intense course of radiation therapy is as effective as the standard course of treatment for early stage breast cancer.
Who is the study for?
This trial is for women over 21 with early stage breast cancer (stage 0, I, or II) who've had a lumpectomy. They should have begun adjuvant therapy within 9 weeks post-surgery and be free from other cancers for at least 5 years. It's aimed at those facing financial/transportation hardships or living far from radiation facilities.Check my eligibility
What is being tested?
The study tests accelerated hypofractionated radiotherapy (AHF-RT) after lumpectomy in patients with early-stage breast cancer. It aims to assess the treatment's safety, effectiveness, impact on quality of life, and cost-effectiveness compared to traditional therapies.See study design
What are the potential side effects?
While specific side effects are not listed here, AHF-RT may include skin irritation, fatigue, swelling in the treated area, and changes in breast appearance. Side effects can vary based on individual patient factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman with breast cancer, had surgery to check my lymph nodes, and must start additional treatment within 9 weeks after my last surgery.
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I have been diagnosed with a specific type of breast cancer.
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My breast cancer is in an early stage (0, I, or II).
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My breast cancer's hormone and HER2 status have been tested.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 5 years post completion of ahf-rt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years post completion of ahf-rt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ipsilateral Breast Tumor Recurrence (IBTR)
Secondary outcome measures
Distant disease-free interval, as determined by mammogram
Quality of Life, as measured by a patient-completed breast cancer specific QOL instrument (EORTC QLQ-BR23)
Recurrence-free survival, as determined by mammogram
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: AHF-RTExperimental Treatment1 Intervention
accelerated hypofractionated radiotherapy (AHF-RT)
30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
accelerated hypofractionated radiotherapy (AHF-RT)
2011
N/A
~160
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,826 Total Patients Enrolled
4 Trials studying Breast Cancer
171 Patients Enrolled for Breast Cancer
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,060 Total Patients Enrolled
2 Trials studying Breast Cancer
117 Patients Enrolled for Breast Cancer
Harriet Eldredge-Hindy, MDPrincipal InvestigatorJames Graham Brown Cancer Center
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged 21 or older.I am currently on hormone therapy, have cosmetic breast implants, or had prior radiation therapy to the chest.I am a woman with cancer spread to non-underarm lymph nodes.I am a woman who has agreed to participate and signed the consent form.My breast cancer has spread to the lymph nodes with visible growth beyond their borders.I am a woman with breast cancer, had surgery to check my lymph nodes, and must start additional treatment within 9 weeks after my last surgery.My breast cancer is at stage III, IV, or classified as T3.I have suspicious lymph nodes that haven't been confirmed negative by a biopsy.I've had a recent physical exam and mammogram.I had breast surgery with all cancer removed, and it may have been in one or more spots.I am a man.I have been diagnosed with a specific type of breast cancer.I am a woman who has been cancer-free for 5+ years from a non-breast cancer and considered low risk for its return.I live far from radiation facilities or face financial/transportation hardships.My breast cancer is in an early stage (0, I, or II).I am a woman with more than 3 cancer-positive lymph nodes under my arm.Women who have certain medical conditions like collagen vascular disease, pregnancy, or psychiatric disorders may not be able to join the study.My surgery showed cancer cells close to the edges or plans include treating nearby lymph nodes with radiation.My breast cancer's hormone and HER2 status have been tested.I have a specific type of breast cancer or history, excluding LCIS treated only by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: AHF-RT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity to join this research endeavor at present?
"As per clinicaltrials.gov, this particular trial has ceased recruitment since its last update on November 2nd 2020. Despite that, there are still 2602 other trials seeking participants at the present moment."
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