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Radiation

Radiation Therapy for Breast Cancer

N/A
Waitlist Available
Led By Douglas W Arthur, M.D.
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic documentation of invasive adenocarcinoma of the breast
Recovery from surgery with healed incision and no signs of infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new way to give radiation therapy to breast cancer patients. The patients will be divided into 3 groups based on their surgery. The trial will assess if this new way of radiation therapy causes less side effects such as lymphedema, pain, and poor cosmetic outcome.

Who is the study for?
This trial is for women with breast cancer who've had surgery, have healed incisions without infection, and tested ER, PR, HER2 on the tumor. They must understand English consent forms, not be pregnant or breastfeeding, use birth control during the study, and meet specific criteria related to their cancer stage and treatment history.Check my eligibility
What is being tested?
The study tests hypofractionated irradiation therapy in women post-breast surgery. It's a phase 2 trial where patients are grouped based on their surgical status: after lumpectomy; post-mastectomy with/without reconstruction plans; or post-mastectomy with reconstruction. Outcomes like lymphedema and pain will be monitored.See study design
What are the potential side effects?
Potential side effects include lymphedema (swelling due to fluid retention), arm function issues, pain in the breast or chest wall area from radiation therapy. For those who underwent lumpectomy or mastectomy with reconstruction, cosmetic outcomes will also be evaluated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is confirmed as invasive adenocarcinoma.
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My surgical wound has healed without any infection.
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I am not pregnant, as confirmed by a test, and I am not postmenopausal or have not had a hysterectomy.
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My breast tumor was tested for ER, PR, and HER2.
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It has been 56 days or less since my last surgery or chemotherapy.
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My breast cancer was completely removed with surgery and the edges of the removed tissue are cancer-free.
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I am mostly able to care for myself and carry out normal activities.
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My cancer was staged T1-3, N1-2a after surgery without prior chemotherapy.
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I had chemotherapy before surgery and my cancer meets certain stage criteria.
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My side effects from chemotherapy that could affect radiation treatment have resolved.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the cumulative incidence of lymphedema during the 3 years following completion of hypofractionated radiation treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (EBRT)Experimental Treatment3 Interventions
External Beam Radiation Therapy (EBRT). Within 10 weeks after the last breast cancer surgery or the last dose of adjuvant chemotherapy, patients undergo hypofractionated RNI five days a week over 3-4 weeks. The two subgroups are Cohort (A) sentinel lymph node (SLN) and Cohort (B) axillary lymph node (ALN) dissection. They are categorized depending on type of axillary surgery and treatment group. The type of axillary surgery is Sentinel lymph node (SLN) biopsy only vs axillary dissection with or without previous SLN biopsy. The treatment groups are lumpectomy vs mastectomy vs mastectomy/reconstruction.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~3070

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
690 Previous Clinical Trials
22,884,772 Total Patients Enrolled
18 Trials studying Breast Cancer
2,307 Patients Enrolled for Breast Cancer
Douglas W Arthur, M.D.Principal InvestigatorMassey Cancer Center

Media Library

External Beam Radiation Therapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT02515110 — N/A
Breast Cancer Research Study Groups: Treatment (EBRT)
Breast Cancer Clinical Trial 2023: External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT02515110 — N/A
External Beam Radiation Therapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02515110 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total patient count for this experiment?

"Affirmative. Clinicaltrials.gov is hosting information about this clinical trial and it has been actively searching for participants since its posting on August 4th 2015, with the last update being December 20th 2021. They are looking to enlist 137 patients from 2 distinct sites."

Answered by AI

Are there any vacancies for those wishing to partake in this experiment?

"Through examination of clinicaltrials.gov, it is evident that this medical study – initially advertised on August 4th 2015 and most recently amended on December 20th 2021 - currently requires volunteers in order to progress further."

Answered by AI
~23 spots leftby Jan 2026