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Photon Therapy
Proton vs. Photon Therapy for Breast Cancer
N/A
Waitlist Available
Led By Justin Bekelman, MD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment
Females or males diagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy with any type of axillary surgery or axillary sampling
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial is testing whether proton therapy or photon therapy is better for treating breast cancer. It will follow patients for side effects, quality of life, and cancer control.
Who is the study for?
This trial is for adults (21+) with non-metastatic breast cancer, regardless of surgery type or breast size. Participants must be planning radiation therapy and have insurance coverage for the treatments tested. People with HIV can join if treated and meet certain health criteria. Excluded are those with prior chest radiation, current metastases, or specific autoimmune conditions.Check my eligibility
What is being tested?
The study compares proton therapy to photon therapy in treating locally advanced breast cancer, focusing on long-term heart health, quality of life, and effectiveness in controlling cancer.See study design
What are the potential side effects?
While not specified here, common side effects from radiation therapies like proton and photon may include skin changes at the treatment site, fatigue, mild swelling in the treated area, and a temporary change in breast color.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for radiation therapy on my breast/chest and lymph nodes, including the internal mammary nodes.
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I have been diagnosed with breast cancer and have had surgery to remove it.
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I have non-metastatic breast cancer at stage I, II, III, or loco-regionally recurrent.
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I am 21 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness of proton therapy vs. photon therapy
Secondary outcome measures
Disease Control
Long Term Survival
Fatigue
+1 moreTrial Design
2Treatment groups
Active Control
Group I: PhotonActive Control1 Intervention
Photon therapy: once a day, 5 days a week, for 5 to 7 weeks
Group II: ProtonActive Control1 Intervention
Proton therapy: once a day, 5 days a week, for 5 to 7 weeks
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
144,426 Total Patients Enrolled
44 Trials studying Breast Cancer
59,611 Patients Enrolled for Breast Cancer
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,996,210 Total Patients Enrolled
7 Trials studying Breast Cancer
1,497,555 Patients Enrolled for Breast Cancer
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
103,826 Total Patients Enrolled
41 Trials studying Breast Cancer
34,095 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There is clear proof from the doctor or scans that the cancer has spread to other parts of the body.I have had radiation therapy on the same side as my current breast or chest cancer.I have not received radiation for my current breast cancer before joining this study.I am scheduled for radiation therapy on my breast/chest and lymph nodes, including the internal mammary nodes.I have been diagnosed with breast cancer and have had surgery to remove it.I have dermatomyositis with high CPK levels or an active rash, or I have scleroderma.I don't have any other serious illnesses that would stop me from participating in the study.I have non-metastatic breast cancer at stage I, II, III, or loco-regionally recurrent.I have cancer in both breasts and will be considered as having left-sided breast cancer.I have had a lumpectomy and any form of breast reconstruction or none at all.My breast size does not limit my eligibility after lumpectomy.I am HIV positive, on HAART, and my CD4 count is ≥ 200.I had a medical check-up relevant to my condition within the last 90 days.My health insurance will cover the study's treatment, but I can pay for some costs if needed.I am 21 years old or older.I've been mostly able to care for myself in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Photon
- Group 2: Proton
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 participants are enrolled in this medical trial?
"To complete this clinical trial, 1278 qualified individuals are required to take part. Participants can join from the University of Florida Health Proton Therapy Institute in Jacksonville, or at Abramson Cancer Center of the University of Pennsylvania in Philadelphia."
Answered by AI
How many research centers are currently conducting this experiment?
"This clinical trial is enlisting participants at 27 sites such as University of Florida Health Proton Therapy Institute in Jacksonville, Abramson Cancer Center of the University of Pennsylvania in Philadelphia, and University Pointe, University of Cincinnati in Hamilton. Additionally there are 24 other recruiting locations throughout the nation."
Answered by AI
Is access to this experiment currently available for participants?
"Affirmative. According to the clinicaltrials.gov database, this trial has been recruiting since February 1st 2016 and was recently modified on November 18th 2022. A total of 1278 subjects are needed from 27 healthcare facilities for enrollment in this study."
Answered by AI
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