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Proton Beam Therapy
Proton Therapy for Breast Cancer
N/A
Waitlist Available
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
History of non-breast malignancies with specific criteria
Age ≥ 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new, accelerated form of partial breast irradiation therapy to see if it is effective and has fewer side effects than current treatments.
Who is the study for?
This trial is for women aged 50 or older with certain types of early-stage breast cancer (Stage 0-IIA), who've had surgery to remove the tumor. They must be within 50 days post-surgery, have no distant spread of cancer, and meet specific health criteria including a good performance status and adequate bone marrow function. Participants should not be pregnant or breastfeeding and willing to use birth control.Check my eligibility
What is being tested?
The study tests accelerated partial breast irradiation using Proton Therapy. It aims to determine if this targeted radiation treatment is feasible as a quicker option compared to traditional whole-breast radiation, by observing short-term and long-term side effects as well as how effective it is in preventing cancer recurrence.See study design
What are the potential side effects?
Possible side effects include skin changes like redness or irritation at the treatment site, fatigue, discomfort in the treated area, swelling or fluid build-up. Long-term effects might involve changes in breast size/shape, tenderness, or rare complications such as heart issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had cancer other than breast cancer.
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I am 50 years old or older.
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I have cancer in both breasts or a history of breast cancer.
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My breast cancer is in the early stages, not spread far.
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My breast cancer is positive for estrogen or progesterone.
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My breast cancer diagnosis was confirmed through tissue examination.
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My cancer has not spread to distant parts of my body.
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I had breast surgery that saved most of my breast.
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My breast cancer has not spread to my lymph nodes or only has tiny amounts.
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I had a procedure to remove areas in my breast that showed up as tiny calcium deposits on an X-ray.
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My lumpectomy cavity is clearly marked and meets the size requirements.
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I am not pregnant or breastfeeding and will use birth control.
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I am able to care for myself and perform daily activities.
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My cancer is in one spot and the tumor is 3 cm or smaller.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events
Side effects data
From 2020 Phase 2 trial • 275 Patients • NCT0091500573%
Fatigue
71%
Radiation Induced Dermatitis
52%
Esophatitis
49%
Cough
45%
Dyspnea
38%
Dysphagia
33%
Odynophagia
30%
Anorexia
24%
Pneumonitis
12%
Pleural effusion
8%
Dehydration
8%
Pneumonia
5%
Pulmonary fibrosis
4%
Fever
2%
Pericardial effusion
2%
Gastro Stricutre
1%
Cardiac Ischemia / Infarction
1%
Hypoxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intensity-modulated (Photon) Radiotherapy (IMRT)
Passive Scattering Proton Therapy (PSPT)
Trial Design
1Treatment groups
Experimental Treatment
Group I: APBI with protonsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Therapy
2009
Completed Phase 2
~280
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,638 Total Patients Enrolled
45 Trials studying Breast Cancer
60,849 Patients Enrolled for Breast Cancer
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,038 Total Patients Enrolled
42 Trials studying Breast Cancer
35,333 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer other than breast cancer.I am 50 years old or older.I have not had any other cancers in the last two years.I have Paget's disease of the nipple.My surgery showed that cancer may still be at the edge of the removed tissue.You need to have a blood test within the last 3 months to make sure your bone marrow is working properly.I have cancer in both breasts or a history of breast cancer.My breast cancer is in the early stages, not spread far.My breast cancer is positive for estrogen or progesterone.My cancer is advanced beyond the early stages.I have received chemotherapy before surgery.I have had radiation therapy on the same side of my chest before.I have a collagen vascular disease.My breast cancer diagnosis was confirmed through tissue examination.My cancer has not spread to distant parts of my body.I had breast surgery that saved most of my breast.My breast cancer has not spread to my lymph nodes or only has tiny amounts.I had a procedure to remove areas in my breast that showed up as tiny calcium deposits on an X-ray.I had my last breast cancer surgery less than 50 days ago.My lumpectomy cavity is clearly marked and meets the size requirements.I had a mammogram or breast MRI within 3 months of my diagnosis.I am not pregnant or breastfeeding and will use birth control.My cancer is in one spot and the tumor is 3 cm or smaller.I have suspicious breast changes without a benign biopsy result.I have multiple breast cancers that cannot be removed with one surgery.I am able to care for myself and perform daily activities.Having breast implants.You have mental health or addiction issues that could make it hard for you to participate in the study.I am a male diagnosed with breast cancer.My breast cancer is of a type that involves the lobules.Lymph nodes outside the armpit area show signs of cancer.You have lumps or abnormal-looking areas in your lymph nodes that haven't been checked by a doctor.My cancer started in multiple places at once.
Research Study Groups:
This trial has the following groups:- Group 1: APBI with protons
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.
Are there still opportunities to join this research endeavor?
"This clinical trial, initially posted on April 1st 2013 and last edited June 3rd 2022, is no longer actively recruiting participants. However, there are presently 2289 other medical studies that require volunteers across the globe."
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