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Radiation Therapy
Radiation Therapy Schedules for Breast Cancer
Phase 2
Recruiting
Led By Karen Hoffman, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
If receiving preoperative radiation therapy: History of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration, and the patient must have no evidence of disease for this prior non-breast cancer
If receiving preoperative radiation therapy: Pathologically-confirmed invasive breast cancer. The clinical stage must be T0-T3, N0-N3b
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 126 months
Awards & highlights
Study Summary
This trial is comparing two different treatment schedules for women who need radiation therapy to their lymph nodes as part of their breast cancer treatment. One schedule takes 6 weeks and the other takes 4 weeks. The purpose of the trial is to see if the shorter schedule will lower the risk of developing arm swelling, also known as lymphedema, after radiation treatment.
Who is the study for?
This trial is for adults with invasive breast cancer who are planning or have had surgery and recommend radiation to lymph nodes near the breast. They must not be pregnant, have no other active cancers, and should not have received certain prior treatments that overlap with this study's area.Check my eligibility
What is being tested?
The trial tests if a shorter 3-week course of radiation therapy to the lymph nodes is as effective in preventing cancer recurrence as the conventional 5-week course. It also examines side effects like arm swelling.See study design
What are the potential side effects?
Potential side effects include skin changes, fatigue, discomfort at the treatment site, and arm swelling (lymphedema), which will be closely monitored during and after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had cancer other than breast cancer, treated it fully, and now show no signs of that cancer.
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My breast cancer is confirmed and falls within early to mid stages before spreading widely.
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I am scheduled for a mastectomy and an axillary evaluation after preoperative radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 126 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 126 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lymphedema rate as assessed by perometry
Secondary outcome measures
Volume of affected and unaffected arm as assessed by perometry
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I: Hypofractionated Regional Nodal Irradiation (RNI)Experimental Treatment4 Interventions
Patients undergo hypofractionated RNI in 15 fractions 5 consecutive days a week for 3 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.
Group II: Arm II: Standard Regional Nodal Irradiation (RNI)Active Control4 Interventions
Patients undergo standard RNI in 25 fractions 5 consecutive days a week for 5 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,788,361 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,924,869 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Karen Hoffman, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had breast cancer in my other breast before and am now getting radiation after surgery.My breast cancer was confirmed by a lab test and fits specific stage criteria.I had or will have breast surgery and checked my lymph nodes, with or without postoperative radiation.I am 18 or older and will receive radiation therapy after surgery.My arm's volume was measured before lymph node surgery.My cancer has spread to distant parts of my body.I have invasive breast cancer in the opposite breast and am receiving preoperative radiation.I had breast cancer in my other breast before starting preoperative radiation.My breast cancer is at stage T4, but I can have surgery to save my breast.I have signs of cancer spread to distant parts of my body after surgery.I will start radiation therapy within 6 months after my last breast cancer surgery or chemotherapy.My surgeon and radiation oncologist recommend preoperative radiation therapy.I had cancer other than breast cancer, treated it fully, and now show no signs of that cancer.I've had radiation therapy in areas that might affect my breast before, but not as part of the PRECISE trial.I had cancer other than breast cancer, treated it fully, and now show no signs of that cancer.My breast cancer is confirmed and falls within early to mid stages before spreading widely.I am scheduled for a mastectomy and an axillary evaluation after preoperative radiation therapy.I am 18 or older and will undergo preoperative radiation therapy.I am pregnant and will undergo radiation therapy after surgery.I am cognitively impaired and will undergo a brief exam before postoperative radiation.I will have a cognitive assessment before my preoperative radiation therapy.My radiation oncologist has recommended radiation treatment to the upper chest area after surgery.I am pregnant and receiving preoperative radiation therapy.My breast cancer is at stage T4 and I am receiving preoperative radiation therapy.My breast cancer has spread to nearby lymph nodes.My breast cancer has spread to the lymph nodes above my collarbone.My radiation treatment plan includes therapy to the areas above and below my collarbone.I've had radiation therapy in areas that could affect my breast but not as part of the PRECISE trial.I plan to use my own tissue for breast reconstruction after radiation.I am getting radiation after surgery and have cancer in the opposite breast.I have been diagnosed with cancer in both breasts and am receiving radiation after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II: Standard Regional Nodal Irradiation (RNI)
- Group 2: Arm I: Hypofractionated Regional Nodal Irradiation (RNI)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many sites are conducting this research?
"Presently, this trial is welcoming patients from The Queen's Medical Center in Honolulu, Hawaii, Orlando Health Cancer Institute in Orlando, California, Scripps- MD Anderson Cancer in San Diego, Georgia and 9 other locations."
Answered by AI
Are we still able to sign up for this experiment?
"From what is published on clinicaltrials.gov, it appears that this trial is still open and looking for patients. The listing was first made on February 23rd, 2017 with the most recent update being September 27th, 2022."
Answered by AI
Does the FDA recognize Quality-of-Life Assessment as a legitimate form of treatment?
"Quality-of-Life Assessment is considered to be a safe medical intervention, as there is Phase 2 trial data supporting its safety. However, no efficacy data exists as of yet."
Answered by AI
How big is the sample size for this research?
"In order to carry out this research, 985 individuals that fit the pre-determined participation requirements are needed. Those who choose to take part in this experiment can do so at various locations, such as The Queen's Medical Center located in Honolulu, Hawaii and Orlando Health Cancer Institute situated in Orlando, California."
Answered by AI
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