Your session is about to expire
← Back to Search
Proton Beam Therapy
Proton Therapy for Early Stage Breast Cancer
Phase 2
Recruiting
Research Sponsored by Proton Collaborative Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a lumpectomy performed, with documented negative surgical margins by 0.2 cm or more. If re-excision results in negative surgical margins 0.2 cm or more, patient is eligible.
Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 years
Awards & highlights
Study Summary
This trial will compare the effects of proton radiation therapy on women with early stage breast cancer.
Who is the study for?
This trial is for women aged 50 or older with early stage breast cancer (Stage 0, I, II) that's ER positive and up to 3.0 cm in size. They must have had a lumpectomy with clear margins and be able to start treatment within specific time frames post-surgery or chemotherapy. Women with invasive lobular histology, previous ipsilateral breast cancer, significant infections, certain genetic mutations like BRCA1/2, or prior chest radiation are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of proton radiotherapy on women with early stage breast cancer. It aims to determine if this type of targeted radiation therapy results in fewer side effects while being as effective as traditional treatments.See study design
What are the potential side effects?
While not explicitly listed here, common side effects from proton radiotherapy may include skin reactions similar to sunburns, fatigue, swelling in the treated area (breast edema), and temporary changes in breast appearance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a lumpectomy with clear margins of at least 0.2 cm.
Select...
My breast cancer is either invasive ductal carcinoma or DCIS.
Select...
My invasive tumor, including all parts, is 3.0 cm or smaller.
Select...
My breast cancer is early stage (0, I, or II) and if stage II, my tumor is 3.0 cm or smaller.
Select...
My cancer is estrogen receptor positive.
Select...
I am female.
Select...
I am 50 years old or older.
Select...
My invasive tumor has been tested for HER2.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess events of freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor.
Secondary outcome measures
Assess number and severity of acute and long-term toxicity of partial breast irradiation using proton therapy for the treatment of early stage breast cancer.
Determine quality of life results.
To assess relationship between breast size and partial breast dosimetry.
+2 moreSide effects data
From 2017 Phase 2 trial • 38 Patients • NCT004950403%
Pneumonitis
3%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose-escalated Proton Therapy for Early-stage Non-small Cell l
Trial Design
1Treatment groups
Experimental Treatment
Group I: Proton RadiotherapyExperimental Treatment1 Intervention
Proton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Radiotherapy
2006
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
Proton Collaborative GroupLead Sponsor
9 Previous Clinical Trials
41,002 Total Patients Enrolled
2 Trials studying Breast Cancer
496 Patients Enrolled for Breast Cancer
Andrew Chang, MDStudy ChairProton Collaborative Group
1 Previous Clinical Trials
720 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your pathology test shows that cancer has spread to the lymphovascular space.You have any suspicious-looking lumps or nodes that haven't been confirmed as harmless through a biopsy.I had a lumpectomy with clear margins of at least 0.2 cm.I understand the requirements for markers or clips for my treatment positioning.I have cancer in more than one location but all tested areas are negative.I have suspicious calcium deposits in my breast, but they are not cancerous.My cancer affects my skin.I have had breast cancer or DCIS in the same breast before.My doctor thinks radiation isn't suitable for my breast condition.My breast cancer is early stage (0, I, or II) and if stage II, my tumor is 3.0 cm or smaller.I do not have major infections, am not pregnant, and do not have HIV/AIDS or specific autoimmune diseases.My breast cancer is either invasive ductal carcinoma or DCIS.My invasive tumor, including all parts, is 3.0 cm or smaller.My cancer is estrogen receptor positive.I can start treatment within 12 weeks after my breast-conserving surgery.I have had breast cancer treatment before or have cancer in the same breast now.I am female.I have Paget's disease of the nipple.I had or will have markers placed within 6 weeks after my surgery.The tissue sample shows a specific type of cancer cells called invasive lobular histology.I can start treatment within 12 weeks after surgery or 8 weeks after chemotherapy ends.I am 50 years old or older.My doctor expects me to live at least 5 more years, considering my age and health conditions.I had markers placed during surgery and scans within 6 weeks after chemotherapy.My invasive tumor has been tested for HER2.My tumor is either single or multiple small ones within 3.0 cm in a single area.My cancer is not a common type like sarcoma or lymphoma.I have a known BRCA 1 or BRCA 2 mutation.I have had radiation therapy on the same side of my chest or breast before.
Research Study Groups:
This trial has the following groups:- Group 1: Proton Radiotherapy
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 any open vacancies in this medical trial?
"Affirmative. According to clinicaltrials.gov, this ongoing research trial is searching for participants. The medical study was first advertised on February 1st 2013 and last updated October 24th 2021; it aspires to enroll 132 patients across 8 different sites."
Answered by AI
To what extent can Proton Radiotherapy adversely affect patients?
"Relative to other treatments, Proton Radiotherapy has a safety rating of 2. This is determined by its Phase 2 status which suggests some data regarding security yet none pertaining to efficacy."
Answered by AI
How extensive is the enrollment for this clinical investigation?
"Affirmative. Per the information provided on clinicaltrials.gov, this medical trial is actively recruiting participants as of now. The study was first announced on February 1st 2013 and was recently updated on October 24th 2021. 8 sites are enrolling a total of 132 patients for participation in the experiment."
Answered by AI
In what number of healthcare institutions is this investigation being conducted?
"This research is happening in 8 locations, including San Diego, Warrenville and Fairfax. To lessen travel demands for participants who join the trial, it's important to select a site that is nearest to you."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Oklahoma Proton Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I would like to try newer approaches to breast cancer treatment.
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger