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Proton Therapy for Early Stage Breast Cancer
Study Summary
This trial will compare the effects of proton radiation therapy on women with early stage breast cancer.
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 2017 Phase 2 trial • 38 Patients • NCT00495040Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Proton Radiotherapy
- 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 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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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