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Hypofractionated Radiation Therapy for Breast Cancer
Study Summary
This trial is testing how well higher doses of radiation therapy over a shorter period of time works to prevent cancer recurrence in patients who have undergone mastectomy.
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.Side effects data
From 2022 Phase 2 trial • 107 Patients • NCT03324802Trial Design
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- I haven't had radiation therapy to my chest, neck, or armpit area; but I may have had radioactive iodine treatment.My mastectomy showed no cancer cells at the edges of the removed tissue.I have never had invasive breast cancer in my other breast.I do not have any active collagen vascular diseases like lupus.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study, even if they have had their tubes tied. This applies to women who are capable of having children and have not gone through menopause for at least a year.My breast cancer is confirmed and not metaplastic.I have never had breast cancer or DCIS in the same breast before, but benign conditions are okay.I haven't had major complications after breast removal that needed unexpected surgery or IV antibiotics.My radiation treatment is planned to target all cancer areas while protecting healthy tissues.My doctor and I plan to start radiation treatment soon, as outlined.My tissue expander is filled with fluid, not air, if I'm undergoing radiation therapy.My last hemoglobin A1C test was within the last 3 months.I agree to use birth control or abstain from sex during radiation therapy.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 5 years.My radiation treatment does not include a boost to the chest wall or scar.I had or plan to have breast reconstruction within 18 months after radiation.My cancer's stage has been determined using the TNM system.My breast cancer is at an early stage and has not spread to distant parts of my body.My breast cancer has not spread to specific areas like the internal mammary nodes.I do not have any health conditions that could shorten my life to under 5 years.I had chemo before surgery for breast cancer and my cancer was at an early stage after surgery.My treatment plan includes radiation to the lymph nodes and chest area.
- Group 1: Group II (hypofractionated radiation therapy)
- Group 2: Group I (radiation therapy)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 different research hospitals participating in this study within the US?
"This study is accepting patients at a number of locations across the United States, including Comprehensive Cancer Centers of Nevada-Summerlin in Las Vegas, Nevada, Urology Specialists of Nevada - Southwest in Greensburg, Pennsylvania, and UPMC Cancer Centers - Arnold Palmer Pavilion in Coral Gables, Florida."
Do physicians have the option of signing up new patients for this treatment program?
"No, this particular trial is not currently recruiting patients according to the latest information on clinicaltrials.gov. This study was originally posted on February 1st, 2018 and was edited for the last time on October 1st, 2021. There are, however, 4701 other trials that are still looking for participants."
Has Hypofractionated Radiation Therapy garnered approval from the FDA?
"There is some evidence from earlier trials to support the safety of Hypofractionated Radiation Therapy, and because this is a Phase 3 trial, it receives a score of 3."
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