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Radiation Therapy
Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer
N/A
Waitlist Available
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
AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.
Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years after treatment
Awards & highlights
Study Summary
This trial is testing a new way to give partial breast radiation that uses less total radiation and could be done at many hospitals with common equipment.
Who is the study for?
This trial is for English-speaking postmenopausal women aged 50 or older with stage 0 or I breast cancer treated by partial mastectomy. They should have no prior non-hormonal therapy for the current cancer, no positive lymph nodes, and must be within 8 weeks of their last definitive breast procedure. Candidates cannot have certain other diseases, a history of other malignancies within the past 5 years (except some skin cancers), or extensive surgery that affects cosmetic outcomes.Check my eligibility
What is being tested?
The study tests Three Fraction Accelerated Partial Breast Irradiation (Tri-APBI) as the only radiation treatment after partial mastectomy in low-risk early-stage breast cancer patients. It aims to minimize adjuvant therapy impact using commonly available equipment at many oncology centers without specialized tools.See study design
What are the potential side effects?
While specific side effects are not listed here, Tri-APBI involves radiation which can cause skin changes, fatigue, discomfort at the treatment site, and potential impacts on nearby organs such as the heart and lungs depending on individual patient factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is early stage, treated with partial mastectomy, and no spread to lymph nodes.
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My breast cancer is hormone receptor positive, HER2 negative, and my tumor is 2 cm or smaller.
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I haven't had hormone, chemo, or biologic therapy before TRI-APBI, but may have started hormone therapy after surgery.
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My breast surgery removed all the cancer with clear margins.
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I was diagnosed with my condition at age 50 or older.
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I am postmenopausal.
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I speak English.
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My radiation therapy will be done at BJH using specific equipment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 5 years after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 5 years after treatment
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 rate
Acute Coryza
Tolerance of Tri-APBI as measured by the rate of late treatment-related grade 3 or higher toxicity or any other grade 4 or 5 toxicity attributed to treatment
Secondary outcome measures
Change in Cosmesis as measured by the Aronson modified Harris scale
Change in Cosmesis as measured by the Breast Retraction Assessment
Change in Cosmesis as measured by the Percent Breast Retraction Assessment
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TRI-APBIExperimental Treatment2 Interventions
Brachytherapy TRI-APBI the PTV is prescribed 7.5 Gy x three fractions given over two to three days OR
External beam TRI-APBI the PTV is prescribed 8.5 Gy x three fractions given over two to three days
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,011 Total Patients Enrolled
46 Trials studying Breast Cancer
5,091 Patients Enrolled for Breast Cancer
Imran Zoberi, M.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
299 Total Patients Enrolled
1 Trials studying Breast Cancer
130 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have multiple tumors in one breast, confirmed by biopsy.I have had treatments like radiation or chemotherapy for my current breast cancer.My breast cancer is early stage, treated with partial mastectomy, and no spread to lymph nodes.I have been diagnosed with lupus, scleroderma, or dermatomyositis.My cancer affects my skin.My breast surgery removed all the cancer with clear margins.I was diagnosed with my condition at age 50 or older.My breast cancer is hormone receptor positive, HER2 negative, and my tumor is 2 cm or smaller.I haven't had hormone, chemo, or biologic therapy before TRI-APBI, but may have started hormone therapy after surgery.It has been more than 8 weeks since my last breast surgery.I have Paget's disease of the nipple.My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.I have a health condition that may limit my life to less than 2 years.My cancer has spread to distant parts of my body.My surgery showed cancer cells at the edge of the removed tissue.My cancer has spread to the lymph nodes under my arm on the same side as my breast cancer.I am postmenopausal.My doctor says my breast is not suitable for a specific radiation therapy due to its condition after surgery.I have not had cancer, except for certain skin cancers or cervical pre-cancer, in the last 5 years.My partial mastectomy has left me with a fair or poor appearance as judged by my doctor.I speak English.My radiation therapy will be done at BJH using specific equipment.
Research Study Groups:
This trial has the following groups:- Group 1: TRI-APBI
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.
Does this trial currently have open enrollment for participants?
"According to clinicaltrials.gov, this study is not presently recruiting new participants; the trial was first launched on August 30th 2018 and last updated on March 15th 2022. Although this particular trial has ended its recruitment period, there are 4862 other medical trials actively accepting patients at the moment."
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