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Brachytherapy
Balloon Brachytherapy and External Beam Irradiation for Breast Cancer (APBI Trial)
N/A
Waitlist Available
Led By Heather A. Morgan, MD
Research Sponsored by Sentara Norfolk General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to radiation, 4 weeks post rt, 6 months post rt, then yearly up to 10 1/2 years post rt
Awards & highlights
APBI Trial Summary
This trial will help determine the long-term effectiveness of accelerated partial breast irradiation for breast cancer patients.
Who is the study for?
This trial is for women over 50 or postmenopausal with stage 0 or 1 breast cancer, having a single tumor ≤2-3 cm based on type. They must have had a lumpectomy with clear margins and no prior treatments for the current cancer except limited hormonal therapy. Men, pregnant/lactating women, those with certain previous cancers or conditions like collagen vascular disease are excluded.Check my eligibility
What is being tested?
The study at Sentara RMH Hahn Cancer Center monitors patients treated with accelerated partial breast irradiation (APBI) over ten years to observe recurrence rates and assess cosmesis and quality of life. APBI will be delivered either by external beam radiation or balloon brachytherapy.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of radiation therapy may include skin irritation at the treatment site, fatigue, breast pain, changes in breast size/shape/coloration (cosmetic changes), and rarely more serious complications such as tissue damage.
APBI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to radiation, 4 weeks post rt, 6 months post rt, then yearly up to 10 1/2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to radiation, 4 weeks post rt, 6 months post rt, then yearly up to 10 1/2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Local and Regional Recurrence after Partial Breast Irradiation as assessed by change in Physical Exam, Mammography, MRI, Scintimammography, Biopsy, and/or Surgical Pathology.
Secondary outcome measures
Number of Participants with Certain Characteristics or Risk Factors in SRMH Population that are Associated with a Higher Risk for Recurrence when Using Partial Breast Irradiation as Assessed by History and Physical, Mammography, Pathology.
Other outcome measures
Number of Participants will have Convenience of Care Assessed by Utilizing the Breast Cancer Treatment Outcome Scale (BCTOS) using Patient Self Reports
Number of Participants will have Cosmetic Results Assessed by Utilizing the Breast Cancer Treatment Outcome Scale (BCTOS) using Patient Self Reports and a Cosmetic Evaluation Will Be Made by the Radiation Oncologist (or Surgeon).
Number of Participants will have Fatigue Results Assessed by Utilizing the Breast Cancer Treatment Outcome Score (BCTOS) using Patient Self Reports.
+2 moreAPBI Trial Design
1Treatment groups
Experimental Treatment
Group I: Partial Breast IrradiationExperimental Treatment2 Interventions
All participants will be treated with partial breast irradiation by utilizing 3D conformal external beam irradiation or balloon brachytherapy. This is not a randomized study.
Find a Location
Who is running the clinical trial?
Sentara Norfolk General HospitalLead Sponsor
11 Previous Clinical Trials
788 Total Patients Enrolled
2 Trials studying Breast Cancer
300 Patients Enrolled for Breast Cancer
Heather A. Morgan, MDPrincipal InvestigatorSentara RMH Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have mental health or addiction issues that could prevent you from participating in the study.I may have had hormone therapy for my current breast cancer, but only for up to 28 days.My breast cancer is found in multiple areas or is spread out.My cancer surgery margins are unclear or very close to the cancer.My breast cancer is either DCIS or invasive but not lobular.I am not currently on hormonal treatments like raloxifene or tamoxifen.The area removed by my breast surgery is less than 25% of my whole breast.I had a lumpectomy with clear margins of 2 mm or more.I will start treatment within 9 weeks after my last breast cancer surgery.My cancer's estrogen and progesterone receptor status has been tested.My post-surgery scan shows I can have targeted radiation therapy.I've been cancer-free for 5+ years, or had certain skin/cervix/colon cancers treated within 5 years.I am a woman eligible for this study.I had breast cancer or DCIS in the same breast before, but LCIS treated with surgery only is okay.I have had a biopsy for any suspicious breast changes, and they were benign.You currently have breast implants, but you can still participate if you have them removed.My cancer is in one area, not larger than 2cm, or 3cm for specific types.I am 50 years or older, or I am postmenopausal.I've had a physical exam and mammogram recently.I have suspicious lymph nodes near my breast without confirmed negative tumor results.My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.I have had a procedure to check if my breast cancer has spread to my armpit nodes.I have cancer in both breasts at the same time.My breast cancer is at stage II, III, or IV.I have a collagen vascular disease like dermatomyositis, lupus, or scleroderma.My breast cancer is in the early stages (0 or 1).I have Paget's disease of the nipple.My treatment plan includes targeted radiation therapy to lymph nodes.I have had radiation therapy on the same side of my chest before.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Partial Breast Irradiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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