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Radiation Therapy
Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer (BreaStBRT Trial)
N/A
Recruiting
Led By Imran Zoberi, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive
All radiation therapy must be planned for delivery at BJH or a BJH/Siteman satellite location with specific stipulations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment through 5 years (estimated to be 5 years)
Awards & highlights
BreaStBRT Trial Summary
This trial will compare the effectiveness of two types of radiation therapy for treating early stage breast cancer.
Who is the study for?
This trial is for postmenopausal women over 50 with early-stage breast cancer (Stage 0 or I) that's hormone receptor-positive and HER2/neu gene negative. Candidates must have had a partial mastectomy with clear margins, no positive lymph nodes, and not received prior non-hormonal therapy for the current cancer. They should be in good health without life-limiting conditions.Check my eligibility
What is being tested?
The study compares two radiation therapies after breast-conserving surgery: one single fraction vs. five fractions of accelerated partial breast irradiation (APBI). It aims to assess which method better controls cancer, has fewer complications, yields better cosmetic results, and improves quality of life.See study design
What are the potential side effects?
Potential side effects from APBI may include skin changes like redness or irritation, fatigue, discomfort at the treatment site, swelling or firmness in the treated area of the breast, and rare risks such as rib fracture or secondary cancers.
BreaStBRT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is hormone receptor positive and not HER2 positive, or it is a non-invasive type that is hormone receptor positive.
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My radiation therapy will be done at BJH or its specific locations.
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I am postmenopausal.
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My breast cancer has not spread to my underarm lymph nodes, confirmed by tests.
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My breast cancer was early stage (0 or I) and treated with a lumpectomy.
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My breast surgery removed all the cancer that could be seen.
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I was 50 years or older when my condition was diagnosed.
BreaStBRT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment through 5 years (estimated to be 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment through 5 years (estimated to be 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of treatment regimen as measured by the ability to complete accrual to the trial in 3 years
Proportion of patients who are free of breast cancer in the treated breast (IBTR)
Secondary outcome measures
Cosmetic Techniques
Change in cosmesis as measured qualitatively by the Aronson modified Harris scale (physician graded)
Change in cosmesis as measured quantitatively by the Breast Retraction Assessment (BRA)
+11 moreBreaStBRT Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 fraction)Experimental Treatment1 Intervention
-External Beam APBI 20 Gy to surgical bed surface (7 Gy to 1 cm from surgical bed in 1 fraction)
Group II: Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 fractions)Experimental Treatment1 Intervention
-External Beam APBI 30 Gy in 5 fractions over 5 days.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,936 Previous Clinical Trials
2,299,722 Total Patients Enrolled
46 Trials studying Breast Cancer
5,038 Patients Enrolled for Breast Cancer
The Foundation for Barnes-Jewish HospitalOTHER
37 Previous Clinical Trials
6,651 Total Patients Enrolled
6 Trials studying Breast Cancer
532 Patients Enrolled for Breast Cancer
Imran Zoberi, M.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
246 Total Patients Enrolled
1 Trials studying Breast Cancer
77 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a health condition that may limit my life to less than 2 years.I have had treatments like radiation or chemotherapy for my current breast cancer.My breast cancer is hormone receptor positive and not HER2 positive, or it is a non-invasive type that is hormone receptor positive.My surgery showed cancer cells at the edge of the removed tissue.My cancer affects my skin.My radiation therapy will be done at BJH or its specific locations.I have Paget's disease of the nipple.I am postmenopausal.My breast cancer has not spread to my underarm lymph nodes, confirmed by tests.I have suspicious lymph nodes near my collarbone or breastbone that have been tested and are not cancerous.I haven't had hormone, chemo, or biologic therapy before my partial breast irradiation, but may have started hormone therapy after surgery.My doctor says my breast is not suitable for a specific type of radiation therapy.It has been over 8 weeks since my last breast surgery.My cancer has spread to distant parts of my body.My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.I have multiple tumors in one breast, confirmed not cancerous by biopsy if there were suspicious areas.My cancer has spread to the lymph nodes under my arm on the same side as my breast cancer.My breast cancer was early stage (0 or I) and treated with a lumpectomy.My breast surgery removed all the cancer that could be seen.My partial mastectomy has left me with a fair or poor appearance as judged by my doctor.I was 50 years or older when my condition was diagnosed.I have been diagnosed with lupus, scleroderma, or dermatomyositis.
Research Study Groups:
This trial has the following groups:- Group 1: Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 fraction)
- Group 2: Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 fractions)
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.
How many participants can the clinical trial accommodate?
"Indeed, the records found on clinicaltrials.gov reveal that this research is actively enrolling individuals to partake in the trial. This medical experiment was initially posted on August 12th 2021 and last amended on March 3rd 2022; it requires 130 participants at one particular location."
Answered by AI
Are there any openings available to participate in this clinical trial?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was first posted on August 12th 2021 is actively recruiting patients. At present, 130 participants are required from 1 site."
Answered by AI
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