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Radiation Therapy
High vs Standard Dose Radiation Therapy for Breast Cancer
Phase 3
Waitlist Available
Led By Frank A. Vicini, MD, FACR
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole breast irradiation with boost without regional nodal irradiation planned
Age ≥ 18
Must not have
Treatment plan that includes regional node irradiation
Intention to administer concurrent chemotherapy for current breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Summary
This trial is studying two different radiation therapy regimens to see how well they work in treating patients with early-stage breast cancer.
Who is the study for?
This trial is for women over 18 who've had early-stage breast cancer surgically removed within the last 50 days. They must not be pregnant, agree to use contraception during treatment, and have no history of certain cancers or severe illnesses. Breast implants are okay, but prior radiation therapy in the same area or plans for chemotherapy alongside this treatment disqualify them.
What is being tested?
The study compares two types of radiation therapy after breast surgery: a higher dose given less frequently with a concurrent boost versus the standard daily dose with a sequential boost. It's randomized, meaning patients are put into groups by chance to see which method works best.
What are the potential side effects?
Radiation therapy can cause skin irritation at the site of treatment, fatigue, swelling in the treated breast (lymphedema), changes in breast size and shape, and rarely more serious complications like heart problems or secondary cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had surgery to remove breast cancer and radiation on the whole breast without treating the lymph nodes.
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I am 18 years old or older.
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I am not pregnant or breastfeeding and agree to use birth control during radiation therapy.
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I am within 50 days of my last breast surgery or chemotherapy.
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I am female.
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My multifocal breast cancer was removed in one surgery with clear margins.
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My cancer has not spread to distant parts of my body.
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My breast surgery removed all visible cancer with clear edges.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My treatment plan includes radiation therapy to the lymph nodes.
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I plan to receive chemotherapy alongside other treatments for my breast cancer.
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I am under 50 and have a low to moderate grade non-invasive breast cancer.
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I have had radiation therapy on the same breast or nearby area before.
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I am 50 or older with a non-invasive breast cancer diagnosis.
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My breast cancer is at an advanced stage (III or IV).
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My breast cancer is invasive but considered low risk for coming back within 5 years after surgery.
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I am a male diagnosed with breast cancer.
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I have unexamined breast lumps or calcium deposits.
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I have multiple breast cancers that can't be removed with one small cut.
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I have cancer in both of my breasts.
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My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.
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I have Paget's disease of the nipple.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With In-breast Recurrence (Local Failure)
Secondary study objectives
Change in Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis Subscale Score From Baseline to 3 Years
Number of Participants by Highest Grade Adverse Event Reported as Definitely, Probably, or Possibly Related to Protocol Treatment
Percentage of Participants Alive
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hypofractionated whole breast irradiation + concurrent boostExperimental Treatment2 Interventions
Hypofractionated whole breast (H-WBI) irradiation with a concurrent boost
Group II: Whole breast irradiation + sequential boostActive Control2 Interventions
Standard fractionation whole breast irradiation (WBI) with sequential boost.
Find a Location
Who is running the clinical trial?
NRG OncologyOTHER
236 Previous Clinical Trials
99,921 Total Patients Enrolled
8 Trials studying Breast Cancer
9,285 Patients Enrolled for Breast Cancer
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
62,572 Total Patients Enrolled
9 Trials studying Breast Cancer
8,057 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,000,646 Total Patients Enrolled
944 Trials studying Breast Cancer
1,541,610 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been cancer-free for at least 5 years, except for non-melanoma skin cancer or cervical carcinoma in situ.My treatment plan includes radiation therapy to the lymph nodes.I plan to receive chemotherapy alongside other treatments for my breast cancer.I had surgery to remove breast cancer and radiation on the whole breast without treating the lymph nodes.I am under 50 and have a low to moderate grade non-invasive breast cancer.I have had radiation therapy on the same breast or nearby area before.For invasive breast cancer, the armpit area must be examined using one of the following methods:I am 18 years old or older.I am not pregnant or breastfeeding and agree to use birth control during radiation therapy.I am within 50 days of my last breast surgery or chemotherapy.I am female.You have a serious, ongoing health problem.I am 50 or older with a non-invasive breast cancer diagnosis.My breast cancer is at an advanced stage (III or IV).My breast cancer is invasive but considered low risk for coming back within 5 years after surgery.It is not possible to clearly see the full size of the area that needs to be removed in the CT scan.I am a male diagnosed with breast cancer.My multifocal breast cancer was removed in one surgery with clear margins.I had a CT scan of the affected breast within the last 28 days for radiation planning.You need to have had a test to check for hormone receptors in your breast tumor according to current guideline recommendations.I have unexamined breast lumps or calcium deposits.I have taken a pregnancy test in the last 14 days and it was negative.My cancer has not spread to distant parts of my body.My breast surgery removed all visible cancer with clear edges.I have multiple breast cancers that can't be removed with one small cut.I have cancer in both of my breasts.My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.I have Paget's disease of the nipple.My recent blood test shows my bone marrow is working well.
Research Study Groups:
This trial has the following groups:- Group 1: Whole breast irradiation + sequential boost
- Group 2: Hypofractionated whole breast irradiation + concurrent boost
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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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