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High vs Standard Dose Radiation Therapy for Breast Cancer
Study Summary
This trial is studying two different radiation therapy regimens to see how well they work in treating patients with early-stage breast cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Whole breast irradiation + sequential boost
- Group 2: Hypofractionated whole breast irradiation + concurrent boost
- 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.
- 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
Are there any health risks associated with Whole breast irradiation delivered by 3-dimensional conformal radiation therapy or intensity modulated radiation therapy?
"Given that this is a Phase 3 trial with efficacy data and multiple rounds of safety testing, our team at Power has rated Whole breast irradiation delivered by 3-dimensional conformal radiation therapy or intensity modulated radiation therapy as having a level of safety at a 3."
Are investigators looking for more test subjects at this time?
"Unfortunately, this study is not taking on any more patients at the moment. However, according to clinicaltrials.gov, which has updated information from as recent as April 6th, 2022, there are 2695 other trials that might be a good match for you."
In how many different areas is this study being conducted?
"At the moment, this clinical trial is enrolling patients at 100 sites. The locations are situated in Akron, East Stroudsburg and Cincinnati along with other locations 100 other locations. If you participate, it would be most convenient to select a location closest to you to minimize travel requirements."
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