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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
Documented negative pregnancy test for women who are not postmenopausal or have not undergone hysterectomy
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 belowSelect...
My breast cancer is confirmed as invasive adenocarcinoma.
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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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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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
~3150
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
700 Previous Clinical Trials
22,886,636 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had breast cancer or DCIS on either side and received radiation therapy.I have had surgery on the same or opposite side armpit before.My breast cancer is advanced (T4) or inflammatory.I have had swelling in one or both of my arms.My breast cancer is confirmed as invasive adenocarcinoma.My body shape or tumor location makes it hard to meet radiation dose needs.My surgical wound has healed without any infection.I am not pregnant, as confirmed by a test, and I am not postmenopausal or have not had a hysterectomy.My cancer has spread to other parts of my body.My cancer has spread to the lymph nodes.I have cancer in both breasts needing radiation therapy.My breast tumor was tested for ER, PR, and HER2.I have had radiation therapy for my current breast cancer.My surgery showed cancer cells at the edge of the removed tissue.I am experiencing healing problems from a recent surgery.It has been 56 days or less since my last surgery or chemotherapy.I have not been diagnosed or treated for cancer other than breast cancer in the last 5 years.I have an active connective tissue disease.My breast cancer was completely removed with surgery and the edges of the removed tissue are cancer-free.I am mostly able to care for myself and carry out normal activities.My cancer was staged T1-3, N1-2a after surgery without prior chemotherapy.I have had radiation therapy on the same or opposite side of my chest before.I had chemotherapy before surgery and my cancer meets certain stage criteria.My side effects from chemotherapy that could affect radiation treatment have resolved.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (EBRT)
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.
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